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Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03903822
Collaborator
(none)
292
Enrollment
76
Locations
8
Arms
11.8
Actual Duration (Months)
3.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Actual Study Start Date :
May 13, 2019
Actual Primary Completion Date :
May 7, 2020
Actual Study Completion Date :
May 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06700841 0.1% cream QD

PF-06700841 0.1% cream applied once daily (QD)

Drug: PF-06700841
PF-06700841 topical cream
Experimental: PF-06700841 0.3% cream QD

PF-06700841 0.3% cream applied once daily (QD)

Drug: PF-06700841
PF-06700841 topical cream
Experimental: PF-06700841 1% cream QD

PF-06700841 1% cream applied once daily (QD)

Drug: PF-06700841
PF-06700841 topical cream
Experimental: PF-06700841 3% cream QD

PF-06700841 3% cream applied once daily (QD)

Drug: PF-06700841
PF-06700841 topical cream
Experimental: PF-06700841 0.3% cream BID

PF-06700841 0.3% cream applied twice daily (BID)

Drug: PF-06700841
PF-06700841 topical cream
Experimental: PF-06700841 1% cream BID

PF-06700841 1% cream applied twice daily (BID)

Drug: PF-06700841
PF-06700841 topical cream
Placebo Comparator: Vehicle cream QD

Vehicle cream applied once daily (QD)

Drug: Vehicle (Placebo)
Vehicle topical cream
Placebo Comparator: Vehicle cream BID

Vehicle cream applied twice daily (BID)

Drug: Vehicle (Placebo)
Vehicle topical cream

Outcome Measures

Primary Outcome Measures

  1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation [Baseline, Week 6]

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Secondary Outcome Measures

  1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation [Baseline, Week 6]

    IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.

  2. Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation [Baseline, Week 6]

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

  3. Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation [Baseline, Weeks 1, 2, 3, 4 and 6]

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  4. Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation [Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  5. Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.

  6. Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation [Baseline, Weeks 1, 2, 3, 4 and 6]

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

  7. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

  8. Number of Participants With Pre-defined Criteria For Vital Signs [Baseline up to Week 6]

    Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.

  9. Number of Participants With Laboratory Abnormalities [Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)]

    Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)<0.5*LLN,>1.5*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin <0.8*LLN,>1.2*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate >1.2*ULN;bilirubin (total, direct, indirect)>1.5*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine, triglycerides, chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery., leu.>= 20;hyaline casts>1;bacteria>20.

  10. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [Baseline up to Week 6]

    Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.

  11. Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  12. Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  13. Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  14. Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  15. Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  16. Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  17. Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  18. Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)]

  19. Change From Baseline in Lipids Profile Values at Week 6 [Baseline, Week 6]

    Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.

  20. Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6 [Baseline, Week 6]

    Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.

  21. Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6 [Baseline, Weeks 2 and 6]

  22. Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6 [Baseline, Weeks 2 and 6]

  23. Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6 [Baseline, Weeks 2 and 6]

    Blood pressure included supine and sitting systolic and diastolic BP.

  24. Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6 [Baseline, Weeks 2 and 6]

  25. Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6 [Baseline, Weeks 2 and 6]

  26. Number of Participants With Each Severity Grade in Local Tolerability Assessments [Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)]

    Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of Atopic Dermatitis for at least 3 months

  • Investigator's Global Assessment (IGA) Score of 2 or 3

  • Eczema Area Severity Index (EASI) score of 3-21

  • Body Surface Area (BSA) of 2-20%

  • Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

  • Other forms of dermatological diseases (other than atopic dermatitis)

  • Fitzpatrick skin type score greater than 5

  • Clinically significant abnormal ECG, vital signs, and laboratory values

  • Infection with HBV, HCV, herpes zoster or tuberculosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Center of Alabama, LLC Birmingham Alabama United States 35244
2 Center for Dermatology and Plastic Surgery/CCT Scottsdale Arizona United States 85260
3 Center for Dermatology and Plastic Surgery Scottsdale Arizona United States 85260
4 California Dermatology & Clinical Research Institute Encinitas California United States 92024
5 First OC Dermatology Fountain Valley California United States 92708
6 Beach Allergy and Asthma Specialty Group, A Medical Corporation Long Beach California United States 90808
7 Clinical Science Institute Santa Monica California United States 90404
8 New England Associates, LLC Bridgeport Connecticut United States 06606
9 Dermatology Physicians of Connecticut Shelton Connecticut United States 06484
10 Yolanda C. Holmes, MD Washington District of Columbia United States 20036
11 Olympian Clinical Research Clearwater Florida United States 33756
12 Accel Research Sites - DeLand Clinical Research Unit DeLand Florida United States 32720
13 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
14 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
15 Precision Imaging Jacksonville Florida United States 32256
16 Solutions Through Advanced Research, Inc Jacksonville Florida United States 32256
17 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
18 Leavitt Medical Associates of Florida d/b/a Ameriderm Research Ormond Beach Florida United States 32174
19 Advanced Medical Research PC Sandy Springs Georgia United States 30328
20 Sneeze, Wheeze & Itch Associates, LLC Normal Illinois United States 61761
21 DS Research New Albany Indiana United States 47150
22 DS Research Louisville Kentucky United States 40241
23 Meridian Clinical Research, LLC Baton Rouge Louisiana United States 70808
24 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
25 Dermatology Consulting Services, PLLC High Point North Carolina United States 27262
26 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
27 Vital Prospects Clinical Research Institute, PC Tulsa Oklahoma United States 74136
28 Health Concepts Rapid City South Dakota United States 57702
29 Tanenbaum Dermatology Center Memphis Tennessee United States 38117
30 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
31 studies in Dermatology, LLC Cypress Texas United States 77433
32 Center for Clinical Studies, LTD.LLP Houston Texas United States 77004
33 Ventavia Research Group LLC Hurst Texas United States 76054
34 Center for Clinical Studies, LTD. LLP Webster Texas United States 77598
35 Summit Clinical Research, LLC Franklin Virginia United States 23851
36 Virginia Dermatology and Skin Cancer Center Norfolk Virginia United States 23502
37 Australian Clinical Research Network Maroubra New South Wales Australia 2035
38 Emeritus Research Camberwell Victoria Australia 3124
39 Sinclair Dermatology East Melbourne Victoria Australia 3002
40 Cabrini Hospital Malvern Victoria Australia 3144
41 Center for Skin and Venereal Diseases EOOD - Sofia Sofia Bulgaria 1404
42 DCC Alexandrovska Sofia Bulgaria 1431
43 Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD Sofia Bulgaria 1463
44 Wiseman Dermatology Research Inc. Winnipeg Manitoba Canada R3M 3Z4
45 SKiN Health Cobourg Ontario Canada K9A 4J9
46 Innovaderm Research Inc. Montreal Quebec Canada H2X 2V1
47 Diex Recherche Sherbrooke Inc. Sherbrooke Quebec Canada J1L 0H8
48 Gentofte Hospital Hellerup Denmark 2900
49 Emovis GmbH Berlin Germany 10629
50 Rothhaar Studien GmbH Berlin Germany 10783
51 ISA - Interdisciplinary Study Association GmbH Berlin Germany 10789
52 Klinikum Bielefeld gem.GmbH Bielefeld Germany 33647
53 Universitätsklinikum Bonn AöR Bonn Germany 53127
54 Universitätsklinikum Frankfurt Frankfurt Germany 60590
55 MENSINGDERMA research GmbH Hamburg Germany 22391
56 MVZ Alstermed GmbH Hamburg Germany 22391
57 Dermatologische Gemeinschaftspraxis Mahlow Germany 15831
58 Klinische Forschung Schwerin GmbH Schwerin Germany 19055
59 Semmelweis Egyetem Altalanos Orvostudomanyi Kar Budapest Hungary 1085
60 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
61 Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza Kecskemet Hungary 6000
62 CRU Hungary Kft. Miskolc Hungary 3529
63 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged Hungary 6720
64 Kitago Dermatology Clinic Sapporo-shi Hokkaido Japan 003-0833
65 Nakatsuhifuka Clinic Kita-ku, Osaka-shi Osaka Japan 531-0072
66 Parkside Hiroo Ladies Clinic Minato-ku Tokyo Japan 106-0047
67 Tanpopo Skin Clinic Ota Ku Tokyo Japan 143-0023
68 Shinjuku Minamiguchi Dermatology Skin Clinic Shinjuku-ku Tokyo Japan 160-0023
69 Medical Corporation Jitai-kai Tachikawa Dermatology Clinic Tachikawa Tokyo Japan 190-0023
70 Aesthetic dermatology clinic of Prof. J. Kisis Riga Latvia LV-1003
71 Health and Aesthetics Ltd Riga Latvia LV-1009
72 Outpatient Clinic of Ventspils Ventspils Latvia LV3601
73 NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c. Bialystok Poland 15-453
74 NASZ LEKARZ Przychodnie Medyczne Torun Poland 87-100
75 MTZ Clinical Research Sp. z o.o Warszawa Poland 02-106
76 WroMedica I. Bielicka, A. Strzalkowska s.c. Wroclaw Poland 51-685

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03903822
Other Study ID Numbers:
  • B7931022
  • 2018-003050-24
First Posted:
Apr 4, 2019
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Mild-to-Moderate Atopic Dermatitis
topical
Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Eczema
PF-06700841

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Period Title: Treatment Phase (6 Weeks)
STARTED 37 37 36 37 36 36 36 37
COMPLETED 28 27 33 32 31 25 31 33
NOT COMPLETED 9 10 3 5 5 11 5 4
Period Title: Treatment Phase (6 Weeks)
STARTED 37 37 36 37 36 36 36 37
COMPLETED 29 29 32 33 32 28 31 31
NOT COMPLETED 8 8 4 4 4 8 5 6

Baseline Characteristics

Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID Total
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Total of all reporting groups
Overall Participants 37 37 36 37 36 36 36 37 292
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
39.1
(16.80)
40.8
(15.35)
43.4
(16.43)
38.4
(12.90)
40.5
(12.30)
42.3
(18.18)
39.4
(17.27)
38.1
(15.34)
40.2
(15.59)
Sex: Female, Male (Count of Participants)
Female
20
54.1%
19
51.4%
24
66.7%
23
62.2%
15
41.7%
19
52.8%
16
44.4%
20
54.1%
156
53.4%
Male
17
45.9%
18
48.6%
12
33.3%
14
37.8%
21
58.3%
17
47.2%
20
55.6%
17
45.9%
136
46.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
3
8.3%
2
5.4%
1
2.8%
3
8.3%
0
0%
4
10.8%
13
4.5%
Not Hispanic or Latino
37
100%
37
100%
32
88.9%
35
94.6%
35
97.2%
33
91.7%
35
97.2%
33
89.2%
277
94.9%
Unknown or Not Reported
0
0%
0
0%
1
2.8%
0
0%
0
0%
0
0%
1
2.8%
0
0%
2
0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
4
10.8%
8
21.6%
4
11.1%
8
21.6%
10
27.8%
9
25%
9
25%
7
18.9%
59
20.2%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
2
0.7%
Black or African American
8
21.6%
7
18.9%
9
25%
6
16.2%
4
11.1%
6
16.7%
5
13.9%
6
16.2%
51
17.5%
White
24
64.9%
22
59.5%
21
58.3%
20
54.1%
21
58.3%
20
55.6%
22
61.1%
24
64.9%
174
59.6%
More than one race
0
0%
0
0%
2
5.6%
2
5.4%
1
2.8%
0
0%
0
0%
0
0%
5
1.7%
Unknown or Not Reported
1
2.7%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
0.3%

Outcome Measures

1. Primary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Least Squares Mean (90% Confidence Interval) [Percent change]
-44.4
-58.3
-64.6
-70.1
-67.9
-47.6
-58.6
-75.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1040
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -13.9
Confidence Interval (2-Sided) 90%
-32.1 to 4.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.04
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0334
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -20.2
Confidence Interval (2-Sided) 90%
-38.3 to -2.1
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.00
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0086
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -25.6
Confidence Interval (2-Sided) 90%
-43.3 to -8.0
Parameter Dispersion Type: Standard Error of the Mean
Value: 10.75
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0158
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23.5
Confidence Interval (2-Sided) 90%
-41.5 to -5.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 10.93
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0879
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.0
Confidence Interval (2-Sided) 90%
-24.3 to 2.4
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.11
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -27.4
Confidence Interval (2-Sided) 90%
-40.7 to -14.1
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.11
Estimation Comments
2. Secondary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
Description IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Time Frame Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Number (90% Confidence Interval) [Percentage of participants]
10.8
29.2%
29.7
80.3%
33.3
92.5%
40.5
109.5%
44.4
123.3%
13.9
38.6%
33.3
92.5%
27.0
73%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0244
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.9
Confidence Interval (2-Sided) 90%
2.4 to 34.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0113
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 22.5
Confidence Interval (2-Sided) 90%
4.8 to 38.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0018
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.7
Confidence Interval (2-Sided) 90%
11.0 to 45.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0007
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 33.6
Confidence Interval (2-Sided) 90%
13.7 to 49.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0289
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.4
Confidence Interval (2-Sided) 90%
1.8 to 36.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1145
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.1
Confidence Interval (2-Sided) 90%
-2.9 to 29.6
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Least Squares Mean (90% Confidence Interval) [Units on a scale]
-3.2
-4.5
-4.6
-4.8
-5.5
-3.6
-4.4
-5.3
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0488
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.31
Confidence Interval (2-Sided) 90%
-2.61 to -0.01
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.790
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0413
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.37
Confidence Interval (2-Sided) 90%
-2.66 to -0.07
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.788
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0200
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.59
Confidence Interval (2-Sided) 90%
-2.86 to -0.32
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.773
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0011
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.33
Confidence Interval (2-Sided) 90%
-3.58 to -1.08
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.758
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0727
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 90%
-1.66 to 0.10
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.535
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0010
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 90%
-2.52 to -0.77
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.534
Estimation Comments
4. Secondary Outcome
Title Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
Description The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Weeks 1, 2, 3, 4 and 6

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 36 35 37 36 36 35 35
At Week 1
16.2
43.8%
16.7
45.1%
20.0
55.6%
29.7
80.3%
44.4
123.3%
13.9
38.6%
28.6
79.4%
25.7
69.5%
At Week 2
24.3
65.7%
30.6
82.7%
42.9
119.2%
48.6
131.4%
61.1
169.7%
25.0
69.4%
45.7
126.9%
37.1
100.3%
At Week 3
21.6
58.4%
38.9
105.1%
48.6
135%
59.5
160.8%
58.3
161.9%
33.3
92.5%
51.4
142.8%
57.1
154.3%
At Week 4
35.1
94.9%
38.9
105.1%
51.4
142.8%
62.2
168.1%
58.3
161.9%
30.6
85%
60.0
166.7%
60.0
162.2%
At Week 6
40.5
109.5%
41.7
112.7%
51.4
142.8%
56.8
153.5%
61.1
169.7%
30.6
85%
60.0
166.7%
60.0
162.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5246
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.5
Confidence Interval (2-Sided) 90%
-14.7 to 16.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3906
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.8
Confidence Interval (2-Sided) 90%
-12.5 to 19.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1193
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.5
Confidence Interval (2-Sided) 90%
-3.2 to 30.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0048
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 28.2
Confidence Interval (2-Sided) 90%
8.8 to 45.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0777
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.7
Confidence Interval (2-Sided) 90%
-2.0 to 31.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1245
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.8
Confidence Interval (2-Sided) 90%
-4.3 to 28.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3322
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.2
Confidence Interval (2-Sided) 90%
-12.2 to 24.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0535
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.5
Confidence Interval (2-Sided) 90%
-0.3 to 36.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0159
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 24.3
Confidence Interval (2-Sided) 90%
4.5 to 41.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0008
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.8
Confidence Interval (2-Sided) 90%
15.4 to 54.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0386
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.7
Confidence Interval (2-Sided) 90%
1.5 to 38.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1485
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.1
Confidence Interval (2-Sided) 90%
-6.4 to 30.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0620
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.3
Confidence Interval (2-Sided) 90%
-0.8 to 34.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0089
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 26.9
Confidence Interval (2-Sided) 90%
6.5 to 44.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0005
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 37.8
Confidence Interval (2-Sided) 90%
17.5 to 54.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0007
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.7
Confidence Interval (2-Sided) 90%
15.4 to 54.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0711
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.1
Confidence Interval (2-Sided) 90%
-2.0 to 37.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0266
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.8
Confidence Interval (2-Sided) 90%
2.7 to 42.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.4173
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.8
Confidence Interval (2-Sided) 90%
-15.3 to 23.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1096
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.3
Confidence Interval (2-Sided) 90%
-4.3 to 35.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0133
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.1 to 45.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0304
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.2
Confidence Interval (2-Sided) 90%
2.6 to 41.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0078
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0078
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.4966
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
-18.4 to 20.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2753
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.9
Confidence Interval (2-Sided) 90%
-9.3 to 30.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1036
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
-4.2 to 35.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0457
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.6
Confidence Interval (2-Sided) 90%
0.4 to 39.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0078
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0078
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
Title Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
Description The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 33 30 32 31 28 30 30 27
At Week 1
0.0
0%
3.3
8.9%
3.1
8.6%
16.1
43.5%
10.7
29.7%
3.3
9.2%
3.3
9.2%
11.1
30%
At Week 2
9.1
24.6%
10.0
27%
9.4
26.1%
19.4
52.4%
25.0
69.4%
10.0
27.8%
13.3
36.9%
33.3
90%
At Week 3
12.1
32.7%
23.3
63%
15.6
43.3%
32.3
87.3%
32.1
89.2%
10.0
27.8%
20.0
55.6%
37.0
100%
At Week 4
18.2
49.2%
26.7
72.2%
28.1
78.1%
35.5
95.9%
50.0
138.9%
10.0
27.8%
30.0
83.3%
37.0
100%
At Week 6
18.2
49.2%
30.0
81.1%
34.4
95.6%
45.2
122.2%
50.0
138.9%
16.7
46.4%
33.3
92.5%
40.7
110%
At Follow-up visit
9.1
24.6%
30.0
81.1%
21.9
60.8%
19.4
52.4%
21.4
59.4%
20.0
55.6%
20.0
55.6%
7.4
20%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2450
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.3
Confidence Interval (2-Sided) 90%
-5.4 to 14.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2575
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.1
Confidence Interval (2-Sided) 90%
-5.3 to 14.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0087
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.1
Confidence Interval (2-Sided) 90%
5.7 to 31.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0392
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.7
Confidence Interval (2-Sided) 90%
0.8 to 25.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 1.0000
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-11.2 to 11.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1528
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.8
Confidence Interval (2-Sided) 90%
-4.9 to 22.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.4989
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.9
Confidence Interval (2-Sided) 90%
-12.7 to 15.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5419
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.3
Confidence Interval (2-Sided) 90%
-13.6 to 14.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1362
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.3
Confidence Interval (2-Sided) 90%
-5.0 to 26.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0541
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.9
Confidence Interval (2-Sided) 90%
-0.4 to 33.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3945
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.3
Confidence Interval (2-Sided) 90%
-12.0 to 19.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0201
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.3
Confidence Interval (2-Sided) 90%
3.9 to 41.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1372
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.2
Confidence Interval (2-Sided) 90%
-5.4 to 28.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3924
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.5
Confidence Interval (2-Sided) 90%
-11.6 to 19.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0311
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.1
Confidence Interval (2-Sided) 90%
2.4 to 38.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0392
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.0
Confidence Interval (2-Sided) 90%
0.8 to 38.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1541
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.0
Confidence Interval (2-Sided) 90%
-6.2 to 26.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0091
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.8 to 45.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2835
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.5
Confidence Interval (2-Sided) 90%
-9.5 to 27.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2700
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.9
Confidence Interval (2-Sided) 90%
-8.7 to 27.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0662
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.3
Confidence Interval (2-Sided) 90%
-1.4 to 36.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0050
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.8
Confidence Interval (2-Sided) 90%
9.2 to 50.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0302
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.0
Confidence Interval (2-Sided) 90%
2.2 to 38.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0091
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.8 to 45.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1561
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.8
Confidence Interval (2-Sided) 90%
-6.5 to 30.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0753
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
-2.7 to 34.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0108
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
5.7 to 46.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0050
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.8
Confidence Interval (2-Sided) 90%
9.2 to 50.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0775
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.7
Confidence Interval (2-Sided) 90%
-2.9 to 35.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0243
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 24.1
Confidence Interval (2-Sided) 90%
3.4 to 43.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0234
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.9
Confidence Interval (2-Sided) 90%
3.5 to 38.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1134
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.8
Confidence Interval (2-Sided) 90%
-2.8 to 29.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1362
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.3
Confidence Interval (2-Sided) 90%
-5.0 to 26.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1029
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.3
Confidence Interval (2-Sided) 90%
-3.4 to 29.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 1.0000
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-17.9 to 17.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.8972
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -12.6
Confidence Interval (2-Sided) 90%
-28.8 to 3.5
Parameter Dispersion Type:
Value:
Estimation Comments
6. Secondary Outcome
Title Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 36 33 35 34 34 36 36
At Week 1
-2.4
-2.9
-16.2
-19.9
-23.0
8.5
-16.5
-17.0
At Week 2
-15.3
-7.2
-38.1
-43.6
-39.0
-2.5
-34.2
-43.1
At Week 3
-17.1
-13.1
-50.6
-55.9
-49.2
-25.2
-39.8
-44.0
At Week 4
-25.9
-20.1
-55.8
-57.9
-56.7
-34.7
-46.4
-57.7
At Week 6
-21.6
-39.4
-59.4
-63.6
-60.3
-31.2
-48.9
-65.0
At Follow-up visit
-23.6
-24.5
-42.7
-37.0
-55.2
-26.3
-31.6
-24.6
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.4781
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 90%
-14.2 to 13.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.33
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0522
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -13.8
Confidence Interval (2-Sided) 90%
-27.8 to 0.2
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.47
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0187
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -17.5
Confidence Interval (2-Sided) 90%
-31.4 to -3.7
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.37
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0080
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -20.6
Confidence Interval (2-Sided) 90%
-34.5 to -6.6
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.45
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0401
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -25.0
Confidence Interval (2-Sided) 90%
-48.6 to -1.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 14.17
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0379
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -25.5
Confidence Interval (2-Sided) 90%
-49.2 to -1.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 14.25
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.7678
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 8.1
Confidence Interval (2-Sided) 90%
-10.1 to 26.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.01
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0193
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -22.8
Confidence Interval (2-Sided) 90%
-40.9 to -4.7
Parameter Dispersion Type: Standard Error of the Mean
Value: 10.94
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0052
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -28.3
Confidence Interval (2-Sided) 90%
-46.5 to -10.2
Parameter Dispersion Type: Standard Error of the Mean
Value: 10.95
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0164
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -23.7
Confidence Interval (2-Sided) 90%
-42.0 to -5.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.03
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0008
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -31.7
Confidence Interval (2-Sided) 90%
-47.8 to -15.6
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.72
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -40.6
Confidence Interval (2-Sided) 90%
-57.0 to -24.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.86
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.6269
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.9
Confidence Interval (2-Sided) 90%
-16.1 to 23.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 12.09
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0027
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -33.5
Confidence Interval (2-Sided) 90%
-53.1 to -13.8
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.87
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0007
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -38.8
Confidence Interval (2-Sided) 90%
-58.5 to -19.2
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.89
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0041
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -32.1
Confidence Interval (2-Sided) 90%
-51.9 to -12.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 12.00
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1054
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -14.6
Confidence Interval (2-Sided) 90%
-33.9 to 4.6
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.61
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0542
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -18.8
Confidence Interval (2-Sided) 90%
-38.1 to 0.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.62
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.6847
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 5.8
Confidence Interval (2-Sided) 90%
-14.2 to 25.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 12.12
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0062
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -29.9
Confidence Interval (2-Sided) 90%
-49.4 to -10.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.82
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0040
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -32.0
Confidence Interval (2-Sided) 90%
-51.6 to -12.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.89
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0054
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -30.8
Confidence Interval (2-Sided) 90%
-50.6 to -11.0
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.97
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1076
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -11.7
Confidence Interval (2-Sided) 90%
-27.2 to 3.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.35
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0082
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -23.0
Confidence Interval (2-Sided) 90%
-38.6 to -7.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.42
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1051
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -17.8
Confidence Interval (2-Sided) 90%
-41.2 to 5.6
Parameter Dispersion Type: Standard Error of the Mean
Value: 14.14
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0034
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -37.8
Confidence Interval (2-Sided) 90%
-60.6 to -15.0
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.80
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0014
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -41.9
Confidence Interval (2-Sided) 90%
-64.8 to -19.0
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.83
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0030
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -38.6
Confidence Interval (2-Sided) 90%
-61.6 to -15.6
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.90
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0289
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -17.7
Confidence Interval (2-Sided) 90%
-33.0 to -2.4
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.22
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0002
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -33.8
Confidence Interval (2-Sided) 90%
-49.2 to -18.4
Parameter Dispersion Type: Standard Error of the Mean
Value: 9.27
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.4739
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 90%
-23.9 to 22.0
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.88
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0789
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -19.1
Confidence Interval (2-Sided) 90%
-41.3 to 3.2
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.43
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1611
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -13.4
Confidence Interval (2-Sided) 90%
-35.7 to 8.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.50
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0124
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -31.6
Confidence Interval (2-Sided) 90%
-54.7 to -8.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.94
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3828
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -5.3
Confidence Interval (2-Sided) 90%
-34.7 to 24.1
Parameter Dispersion Type: Standard Error of the Mean
Value: 17.68
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5383
Comments
Method Mixed Model Repeated Measure
Comments
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 1.7
Confidence Interval (2-Sided) 90%
-27.9 to 31.3
Parameter Dispersion Type: Standard Error of the Mean
Value: 17.80
Estimation Comments
7. Secondary Outcome
Title Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 1, 2, 3, 4 and 6

Outcome Measure Data

Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. NRI method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
At Week 1
5.4
14.6%
0.0
0%
19.4
53.9%
5.4
14.6%
16.7
46.4%
0.0
0%
13.9
38.6%
21.6
58.4%
At Week 2
8.1
21.9%
10.8
29.2%
27.8
77.2%
24.3
65.7%
38.9
108.1%
13.9
38.6%
25.0
69.4%
32.4
87.6%
At Week 3
5.4
14.6%
16.2
43.8%
36.1
100.3%
43.2
116.8%
41.7
115.8%
19.4
53.9%
19.4
53.9%
43.2
116.8%
At Week 4
24.3
65.7%
21.6
58.4%
38.9
108.1%
43.2
116.8%
50.0
138.9%
22.2
61.7%
36.1
100.3%
48.6
131.4%
At Week 6
35.1
94.9%
32.4
87.6%
52.8
146.7%
54.1
146.2%
50.0
138.9%
16.7
46.4%
36.1
100.3%
51.4
138.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.8964
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.4
Confidence Interval (2-Sided) 90%
-16.1 to 2.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0391
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.0
Confidence Interval (2-Sided) 90%
1.0 to 28.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 1.0000
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-10.8 to 10.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0708
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.3
Confidence Interval (2-Sided) 90%
-1.4 to 25.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0122
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.9
Confidence Interval (2-Sided) 90%
4.7 to 27.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0016
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 21.6
Confidence Interval (2-Sided) 90%
11.0 to 35.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.3950
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.7
Confidence Interval (2-Sided) 90%
-9.8 to 16.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0173
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.7
Confidence Interval (2-Sided) 90%
4.2 to 35.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0327
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
1.4 to 31.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0011
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 30.8
Confidence Interval (2-Sided) 90%
13.2 to 46.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1348
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.1
Confidence Interval (2-Sided) 90%
-5.0 to 27.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0328
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.5
Confidence Interval (2-Sided) 90%
1.5 to 34.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0769
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.8
Confidence Interval (2-Sided) 90%
-1.8 to 24.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0005
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 30.7
Confidence Interval (2-Sided) 90%
13.2 to 46.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 37.8
Confidence Interval (2-Sided) 90%
22.1 to 53.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0001
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.3
Confidence Interval (2-Sided) 90%
19.7 to 51.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 1.0000
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-16.5 to 16.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0173
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.8
Confidence Interval (2-Sided) 90%
4.5 to 41.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5663
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.7
Confidence Interval (2-Sided) 90%
-19.9 to 14.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1243
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.6
Confidence Interval (2-Sided) 90%
-3.8 to 32.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0460
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.9
Confidence Interval (2-Sided) 90%
-0.5 to 36.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0130
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 25.7
Confidence Interval (2-Sided) 90%
4.8 to 43.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1194
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.9
Confidence Interval (2-Sided) 90%
-4.2 to 31.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0097
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 26.4
Confidence Interval (2-Sided) 90%
6.5 to 44.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5556
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.7
Confidence Interval (2-Sided) 90%
-21.0 to 16.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0761
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.6
Confidence Interval (2-Sided) 90%
-2.5 to 36.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0583
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.9
Confidence Interval (2-Sided) 90%
-0.8 to 37.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1245
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.9
Confidence Interval (2-Sided) 90%
-5.0 to 33.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0382
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.4
Confidence Interval (2-Sided) 90%
1.5 to 36.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0011
Comments
Method Chan and Zhang Exact Method
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 34.7
Confidence Interval (2-Sided) 90%
13.2 to 51.4
Parameter Dispersion Type:
Value:
Estimation Comments
8. Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Time Frame Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
TEAEs
18
48.6%
17
45.9%
11
30.6%
12
32.4%
10
27.8%
17
47.2%
9
25%
14
37.8%
SAEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
9. Secondary Outcome
Title Number of Participants With Pre-defined Criteria For Vital Signs
Description Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.
Time Frame Baseline up to Week 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 21 20 25 18 21 19 22 22
Sitting DBP: Change >= 20 mm Hg increase
0
0%
0
0%
1
2.8%
2
5.4%
0
0%
0
0%
0
0%
0
0%
Sitting DBP: Change >= 20mmHg decrease
1
2.7%
0
0%
0
0%
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
Supine DBP: Value <50 mmHg
0
0%
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
0
0%
Supine DBP: Change >= 20mmHg increase
0
0%
1
2.7%
1
2.8%
2
5.4%
1
2.8%
0
0%
1
2.8%
0
0%
Supine DBP: Change >= 20mmHg decrease
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
Sitting SBP: <90mmHg
0
0%
0
0%
0
0%
1
2.7%
0
0%
0
0%
0
0%
0
0%
Sitting SBP: change >= 30mmHg increase
0
0%
0
0%
0
0%
1
2.7%
0
0%
0
0%
0
0%
1
2.7%
Sitting SBP: change >= 30mmHg decrease
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
0
0%
0
0%
Supine SBP: Change >= 30mmHg increase
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
1
2.8%
1
2.8%
0
0%
Supine SBP: Change >= 30mmHg decrease
0
0%
0
0%
1
2.8%
0
0%
0
0%
0
0%
2
5.6%
0
0%
Supine SBP: Value <90mmHg
0
0%
1
2.7%
1
2.8%
0
0%
0
0%
0
0%
0
0%
0
0%
10. Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Description Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)<0.5*LLN,>1.5*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin <0.8*LLN,>1.2*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate >1.2*ULN;bilirubin (total, direct, indirect)>1.5*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine, triglycerides, chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery., leu.>= 20;hyaline casts>1;bacteria>20.
Time Frame Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 35 35 37 35 36 36 36
Count of Participants [Participants]
26
70.3%
22
59.5%
23
63.9%
22
59.5%
16
44.4%
21
58.3%
24
66.7%
24
64.9%
11. Secondary Outcome
Title Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Description Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
Time Frame Baseline up to Week 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 8 6 7 9 10 6 7 7
PR interval : value >280 msec
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
0
0%
0
0%
PR interval : %change>=25/50%
0
0%
1
2.7%
1
2.8%
0
0%
1
2.8%
0
0%
2
5.6%
0
0%
QRS interval: value >120 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
2.8%
1
2.7%
QRS interval: %Change>=50%
0
0%
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
0
0%
QTCF: 450 msec
0
0%
0
0%
1
2.8%
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
QTCF: 30<=Change<60
0
0%
1
2.7%
1
2.8%
1
2.7%
1
2.8%
2
5.6%
1
2.8%
0
0%
12. Secondary Outcome
Title Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 32 32 32 33 32 32 34 33
Change at week 1
0.4
(25.99)
-7.4
(30.20)
-5.3
(16.99)
-9.3
(22.65)
-18.4
(33.42)
-8.0
(34.51)
-8.0
(19.37)
-4.3
(29.08)
Change at week 2
-8.8
(21.56)
-7.8
(27.99)
-1.9
(18.18)
-8.8
(23.70)
-15.8
(42.19)
-0.3
(22.81)
-8.0
(22.31)
-4.9
(24.49)
Change at week 4
-8.6
(23.93)
-5.4
(22.87)
-9.3
(19.61)
-12.1
(28.54)
-16.3
(33.97)
-1.0
(29.29)
-19.5
(19.94)
-3.7
(24.96)
Change at week 6
-8.8
(18.25)
-8.1
(32.02)
-1.5
(32.42)
-6.4
(28.53)
-18.2
(33.86)
-9.7
(20.68)
-11.2
(22.34)
-7.0
(24.65)
Change at follow-up visit
-12.3
(24.82)
-12.0
(28.83)
4.0
(43.45)
-2.7
(26.27)
-15.1
(38.23)
-11.3
(29.39)
-13.3
(25.37)
0.2
(16.48)
13. Secondary Outcome
Title Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 35 34 36 36 35
Protein: change at week 1
-0.01
(0.439)
-0.04
(0.294)
-0.14
(0.433)
-0.04
(0.264)
-0.03
(0.421)
-0.10
(0.360)
-0.01
(0.344)
-0.02
(0.301)
Protein:change at week 2
-0.09
(0.383)
0.03
(0.303)
-0.18
(0.402)
-0.01
(0.275)
0.01
(0.561)
0.02
(0.503)
-0.04
(0.286)
-0.10
(0.299)
Protein: change at week 4
-0.10
(0.380)
0.07
(0.315)
-0.08
(0.429)
-0.03
(0.341)
-0.04
(0.465)
-0.18
(0.292)
-0.15
(0.242)
0.03
(0.280)
Protein: change at week 6
-0.13
(0.403)
0.13
(0.379)
-0.19
(0.452)
0.01
(0.368)
-0.03
(0.405)
-0.10
(0.424)
-0.09
(0.368)
-0.09
(0.310)
Protein: change at follow-up visit
-0.07
(0.341)
0.05
(0.457)
-0.15
(0.481)
-0.04
(0.404)
0.03
(0.481)
-0.18
(0.471)
-0.09
(0.398)
0.02
(0.299)
Albumin:change at week 1
-0.04
(0.269)
-0.05
(0.205)
-0.10
(0.283)
-0.02
(0.177)
0.00
(0.256)
-0.05
(0.218)
-0.03
(0.246)
0.00
(0.169)
Albumin:change at week 2
-0.06
(0.235)
0.02
(0.201)
-0.10
(0.256)
-0.02
(0.204)
-0.01
(0.283)
0.02
(0.266)
-0.03
(0.174)
-0.06
(0.202)
Albumin: change at week 4
-0.08
(0.245)
0.07
(0.172)
-0.08
(0.285)
0.01
(0.239)
0.04
(0.292)
-0.10
(0.232)
-0.08
(0.180)
0.03
(0.224)
Albumin:change at week 6
-0.08
(0.259)
0.08
(0.245)
-0.14
(0.333)
-0.02
(0.269)
-0.00
(0.218)
-0.03
(0.252)
-0.07
(0.244)
-0.05
(0.227)
Albumin: change at follow-up visit
-0.06
(0.247)
0.10
(0.260)
-0.09
(0.277)
-0.04
(0.295)
-0.01
(0.346)
-0.09
(0.262)
-0.02
(0.211)
0.06
(0.181)
14. Secondary Outcome
Title Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 35 34 34 36 35
Urea nitrogen: change at week 1
0.9
(4.57)
0.6
(3.04)
0.1
(3.12)
1.0
(3.19)
1.0
(3.05)
0.2
(2.19)
0.4
(3.38)
-0.1
(2.65)
Urea nitrogen: change at week 2
0.8
(3.89)
0.0
(2.71)
0.6
(3.54)
0.9
(3.18)
0.5
(3.63)
0.6
(4.19)
0.8
(2.99)
0.4
(3.28)
Urea nitrogen: change at week 4
0.6
(3.39)
0.0
(3.04)
-0.0
(2.67)
1.4
(3.06)
0.5
(3.84)
-0.7
(2.96)
1.3
(2.81)
-0.2
(3.61)
Urea nitrogen: change at week 6
0.7
(2.84)
-0.2
(3.11)
-0.6
(3.61)
0.9
(3.27)
0.3
(3.82)
-0.8
(3.24)
0.2
(3.52)
-0.4
(3.69)
Urea nitrogen: change at follow-up visit
0.0
(3.17)
-0.3
(3.13)
0.4
(2.60)
1.2
(4.22)
0.2
(2.87)
0.8
(3.78)
0.5
(3.42)
0.1
(3.78)
Urate:change at week 1
0.16
(0.807)
0.01
(0.606)
0.16
(0.678)
-0.01
(0.561)
0.00
(0.739)
0.05
(0.661)
-0.02
(0.704)
-0.14
(0.890)
Urate: change at week 2
0.30
(0.990)
-0.11
(0.655)
0.12
(0.617)
-0.03
(0.649)
-0.15
(0.842)
0.27
(1.025)
-0.03
(0.718)
-0.37
(1.059)
Urate: change at week 4
0.21
(0.497)
0.14
(0.731)
0.06
(0.756)
-0.06
(0.621)
-0.14
(0.856)
0.22
(0.806)
-0.21
(0.663)
-0.16
(0.713)
Urate: change at week 6
0.13
(0.728)
0.07
(0.984)
-0.02
(0.831)
0.06
(0.630)
-0.02
(0.649)
0.06
(0.534)
-0.11
(0.827)
-0.21
(1.084)
Urate: change at follow- up visit
-0.11
(0.721)
-0.33
(0.753)
0.05
(0.763)
-0.21
(0.554)
-0.02
(0.810)
0.02
(0.590)
-0.08
(0.677)
-0.20
(0.989)
Calcium:change at week 1
0.01
(0.419)
0.01
(0.259)
-0.06
(0.377)
-0.02
(0.248)
0.07
(0.386)
-0.02
(0.303)
-0.01
(0.295)
0.09
(0.318)
Calcium: change at week 2
-0.08
(0.417)
0.00
(0.268)
-0.10
(0.362)
0.05
(0.296)
0.07
(0.423)
0.03
(0.389)
-0.10
(0.293)
-0.01
(0.244)
Calcium: change at week 4
-0.04
(0.354)
0.11
(0.329)
-0.07
(0.345)
0.05
(0.272)
0.00
(0.376)
-0.08
(0.309)
-0.03
(0.257)
0.10
(0.341)
Calcium: change at week 6
-0.04
(0.355)
0.10
(0.303)
-0.21
(0.393)
0.03
(0.315)
0.00
(0.397)
-0.05
(0.335)
-0.05
(0.464)
-0.04
(0.337)
Calcium: change at follow-up visit
0.00
(0.317)
-0.01
(0.345)
-0.08
(0.409)
0.00
(0.323)
0.10
(0.441)
-0.05
(0.419)
0.01
(0.378)
0.05
(0.356)
Glucose:change at week 1
4.9
(8.73)
5.7
(13.97)
3.4
(14.62)
4.5
(8.60)
4.4
(16.14)
4.5
(29.90)
5.6
(13.14)
3.3
(13.58)
Glucose: change at week 2
9.7
(23.71)
1.2
(17.34)
0.6
(10.97)
3.2
(12.63)
3.1
(10.00)
-1.9
(13.51)
7.9
(16.67)
2.7
(18.07)
Glucose: change at week 4
7.3
(15.60)
0.5
(12.50)
-1.2
(15.86)
4.5
(13.99)
2.8
(20.20)
1.3
(24.01)
10.7
(26.13)
3.4
(18.33)
Glucose: change at week 6
3.5
(9.19)
2.4
(17.55)
-1.7
(10.62)
2.1
(13.80)
-0.5
(9.77)
-3.4
(16.37)
4.3
(12.23)
1.5
(12.62)
Glucose: change at follow -up visit
4.5
(11.58)
2.2
(11.45)
4.8
(13.28)
4.6
(14.77)
6.0
(13.79)
6.2
(16.75)
9.1
(17.21)
2.0
(22.43)
15. Secondary Outcome
Title Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 35 34 34 36 35
Sodium: change at week 1
0.1
(2.34)
-0.0
(1.77)
-0.7
(2.04)
-0.6
(2.17)
-0.4
(3.50)
0.4
(1.97)
0.0
(2.08)
-0.1
(3.39)
Sodium: change at week 2
-0.5
(2.23)
-0.3
(1.89)
-0.1
(2.39)
-0.2
(2.18)
-0.4
(3.61)
-0.2
(2.61)
-0.5
(2.20)
-0.3
(3.45)
Sodium:change at week 4
-0.3
(2.70)
0.6
(1.83)
-0.2
(2.44)
-0.7
(2.71)
-0.4
(3.08)
-0.4
(2.72)
-0.1
(1.77)
-0.3
(3.28)
Sodium:change at week 6
-0.8
(2.31)
0.0
(2.39)
-0.2
(2.23)
-0.9
(2.40)
-0.9
(3.55)
0.9
(2.50)
-0.1
(2.23)
-0.5
(2.49)
Sodium: change at follow up
-0.4
(3.26)
0.5
(2.50)
-0.1
(2.45)
-0.3
(2.41)
-0.8
(3.59)
0.7
(1.94)
-0.1
(2.46)
0.1
(3.32)
Potassium: change at week 1
-0.00
(0.363)
0.08
(0.282)
0.03
(0.372)
0.02
(0.347)
0.07
(0.343)
0.01
(0.337)
0.00
(0.429)
0.20
(0.464)
Potassium:change at week 2
-0.14
(0.367)
0.04
(0.298)
-0.07
(0.338)
0.04
(0.359)
0.07
(0.346)
0.00
(0.245)
-0.16
(0.438)
-0.02
(0.322)
Potassium: change at week 4
0.01
(0.389)
-0.06
(0.285)
-0.02
(0.350)
-0.01
(0.327)
0.05
(0.375)
-0.09
(0.300)
-0.03
(0.415)
0.26
(0.350)
Potassium: change at week 6
-0.09
(0.373)
0.03
(0.295)
-0.06
(0.332)
0.03
(0.407)
-0.06
(0.262)
-0.06
(0.309)
-0.10
(0.355)
0.09
(0.388)
Potassium: change at follow-up visit
-0.11
(0.379)
0.10
(0.375)
0.03
(0.394)
0.04
(0.351)
0.12
(0.358)
0.05
(0.293)
-0.09
(0.475)
0.26
(0.460)
Chloride: change at week 1
0.1
(2.11)
0.3
(1.86)
0.3
(1.57)
0.0
(2.54)
0.0
(2.66)
0.6
(2.11)
0.5
(2.02)
0.5
(2.83)
Chloride: change at week 2
-0.2
(2.52)
-0.2
(2.08)
0.7
(2.03)
0.2
(2.50)
-0.2
(2.87)
0.4
(2.70)
0.4
(2.15)
0.2
(2.99)
Chloride: change at week 4
0.3
(2.05)
0.6
(1.89)
0.2
(2.68)
-0.4
(2.23)
-0.3
(2.16)
0.3
(3.28)
1.0
(2.21)
-0.2
(2.57)
Chloride:change at week 6
-0.6
(1.98)
0.1
(2.27)
0.0
(2.34)
-0.5
(2.44)
-0.4
(3.05)
0.5
(2.93)
0.9
(2.73)
0.0
(2.32)
Chloride: change at follow-up visit
0.6
(2.97)
-0.3
(2.16)
0.8
(2.64)
0.1
(2.41)
-0.4
(2.90)
1.3
(2.11)
0.3
(2.35)
0.4
(3.16)
Bicarbonate: change at week 1
0.13
(2.548)
-0.38
(1.759)
-0.20
(1.965)
-0.18
(1.768)
0.28
(1.638)
0.09
(2.209)
-0.21
(2.388)
-0.02
(1.651)
Bicarbonate: change at week 2
0.08
(2.229)
-0.40
(2.151)
-0.51
(1.956)
0.10
(2.129)
-0.13
(1.931)
-0.15
(2.341)
-0.60
(2.354)
-0.07
(1.828)
Bicarbonate: change at week 4
0.21
(2.739)
0.05
(2.128)
-0.24
(2.484)
0.34
(1.868)
0.02
(2.011)
0.14
(1.286)
-0.00
(2.695)
0.02
(1.704)
Bicarbonate: change at week 6
0.52
(2.560)
-0.44
(2.598)
0.66
(2.132)
0.27
(2.204)
0.12
(2.407)
0.63
(2.096)
-0.19
(2.038)
-0.20
(2.217)
Bicarbonate: change at follow-up visit
-0.02
(2.916)
0.66
(2.209)
0.41
(2.056)
0.75
(2.386)
0.43
(2.162)
0.08
(1.643)
0.18
(2.300)
1.09
(2.049)
16. Secondary Outcome
Title Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 37 33 34 34 33 35 34
Change at week 1
-0.01
(0.790)
-0.22
(0.620)
-0.36
(0.775)
-0.12
(0.678)
-0.26
(0.726)
-0.19
(0.698)
-0.21
(0.584)
-0.27
(0.679)
Change at week 2
-0.16
(0.636)
-0.09
(0.566)
-0.64
(0.715)
-0.24
(0.657)
-0.22
(0.798)
-0.16
(0.830)
-0.25
(0.625)
-0.32
(0.793)
Change at week 4
0.03
(0.725)
-0.17
(0.630)
-0.48
(0.659)
-0.25
(0.628)
-0.06
(0.821)
-0.27
(0.789)
-0.32
(0.701)
-0.20
(0.658)
Change at week 6
-0.13
(0.832)
-0.06
(0.614)
-0.48
(0.767)
-0.03
(0.617)
-0.11
(0.775)
-0.22
(0.724)
-0.21
(0.833)
-0.28
(0.683)
Change at follow-up visit
0.05
(0.613)
-0.04
(0.717)
-0.49
(0.777)
-0.09
(0.784)
0.00
(0.773)
-0.27
(0.756)
-0.12
(0.826)
-0.18
(0.740)
17. Secondary Outcome
Title Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 34 34 33 35 34
Hematocrit: change at week 1
0.2
(2.51)
-0.8
(2.11)
-1.3
(2.61)
-0.4
(2.27)
-0.8
(2.41)
-0.5
(1.97)
-0.9
(2.04)
-0.9
(2.30)
Hematocrit: change at week 2
-0.5
(2.19)
-0.8
(2.12)
-1.8
(2.42)
-0.9
(2.32)
-0.7
(2.58)
-0.9
(2.55)
-0.7
(2.24)
-1.0
(2.61)
Hematocrit: change at week 4
0.0
(2.45)
-0.8
(1.96)
-1.8
(2.06)
-0.8
(2.34)
0.0
(2.73)
-1.0
(2.34)
-0.9
(2.29)
-0.5
(2.56)
Hematocrit: change at week 6
-0.6
(2.47)
-0.9
(1.93)
-1.6
(2.64)
-0.7
(2.23)
-0.6
(2.51)
-1.1
(1.98)
-1.1
(2.84)
-0.8
(2.60)
Hematocrit: change at follow-up (FU) visit
0.3
(2.49)
-0.7
(2.24)
-1.4
(3.05)
-0.7
(2.39)
-0.2
(2.50)
-0.6
(2.20)
-0.6
(2.73)
-0.3
(2.78)
Reticulocytes/Erythrocytes change at week 1
0.03
(0.317)
0.14
(0.378)
0.02
(0.483)
0.06
(0.364)
0.11
(0.318)
0.01
(0.320)
0.04
(0.355)
0.01
(0.329)
Reticulocytes/Erythrocytes: change at week 2
-0.03
(0.382)
0.17
(0.325)
0.09
(0.413)
-0.02
(0.473)
0.19
(0.443)
-0.10
(0.318)
0.06
(0.315)
-0.01
(0.389)
Reticulocytes/Erythrocytes: change at week 4
0.16
(0.596)
-0.08
(0.359)
0.01
(0.460)
0.19
(0.429)
0.10
(0.409)
0.03
(0.290)
0.04
(0.446)
0.05
(0.374)
Reticulocytes/Erythrocytes: change at week 6
-0.06
(0.382)
0.02
(0.361)
0.02
(0.473)
0.01
(0.486)
0.15
(0.399)
-0.15
(0.310)
-0.01
(0.355)
0.01
(0.463)
Reticulocytes/Erythrocytes:change at FU visit
-0.11
(0.396)
-0.02
(0.384)
0.10
(0.435)
-0.10
(0.398)
-0.03
(0.298)
-0.09
(0.331)
-0.19
(0.395)
0.11
(0.448)
Lymphocytes/Leukocytes: change at week 1
-0.43
(6.772)
0.68
(5.814)
2.33
(5.616)
0.06
(4.765)
1.31
(6.259)
0.59
(5.179)
0.49
(5.509)
1.79
(6.269)
Lymphocytes/Leukocytes: change at week 2
0.20
(6.175)
0.84
(7.544)
1.68
(5.208)
1.50
(5.639)
0.23
(6.175)
0.50
(5.405)
0.72
(6.638)
0.86
(7.264)
Lymphocytes/Leukocytes: change at week 4
1.58
(7.591)
0.51
(7.297)
1.43
(5.298)
0.43
(7.586)
2.41
(6.577)
-1.38
(5.415)
1.07
(5.739)
0.56
(7.264)
Lymphocytes/Leukocytes: change at week 6
-0.92
(6.701)
-0.06
(5.461)
0.82
(6.685)
1.28
(5.881)
1.65
(5.818)
0.50
(4.452)
-0.04
(5.300)
1.52
(7.266)
Lymphocytes/Leukocytes: change at follow-up visit
1.53
(6.219)
1.25
(4.974)
1.61
(6.597)
-0.85
(6.367)
1.34
(6.165)
0.22
(6.315)
0.07
(5.103)
2.48
(6.914)
Neutrophils/Leukocytes: change at week 1
0.57
(7.515)
-0.95
(6.957)
-2.93
(6.191)
0.30
(5.755)
-0.96
(7.843)
-0.17
(5.769)
-1.87
(6.873)
-1.44
(6.580)
Neutrophils/Leukocytes: change at week 2
-0.12
(7.827)
-0.34
(8.219)
-1.70
(6.037)
-1.50
(6.578)
-0.24
(6.146)
-0.49
(6.665)
-1.04
(7.376)
-0.56
(8.017)
Neutrophils/Leukocytes: change at week 4
-1.42
(8.812)
-0.30
(7.754)
-1.52
(6.661)
0.06
(8.536)
-2.25
(7.468)
1.65
(6.622)
-1.42
(6.498)
-0.45
(7.362)
Neutrophils/Leukocytes: change at week 6
0.95
(8.648)
-0.58
(7.009)
-0.64
(6.833)
-1.14
(6.872)
-1.15
(6.969)
-0.56
(5.699)
0.13
(6.029)
-1.01
(8.445)
Neutrophils/Leukocytes: change at follow-up visit
-1.71
(7.046)
-0.65
(6.057)
-1.86
(6.892)
1.32
(7.355)
-1.32
(6.559)
-0.41
(6.961)
-0.71
(6.590)
-2.04
(7.700)
Basophils/Leukocytes: change at week 1
-0.06
(0.431)
-0.02
(0.690)
-0.06
(0.524)
0.08
(0.319)
0.03
(0.515)
-0.03
(0.291)
-0.01
(0.411)
-0.01
(0.570)
Basophils/Leukocytes: change at week 2
-0.02
(0.304)
0.01
(0.493)
-0.09
(0.342)
0.02
(0.323)
-0.03
(0.532)
0.03
(0.355)
-0.06
(0.624)
-0.24
(0.709)
Basophils/Leukocytes: change at week 4
-0.07
(0.485)
0.06
(0.651)
-0.03
(0.420)
0.01
(0.402)
-0.08
(0.712)
-0.05
(0.362)
-0.01
(0.465)
-0.10
(0.464)
Basophils/Leukocytes: change at week 6
-0.07
(0.272)
0.11
(0.809)
-0.12
(0.480)
0.08
(0.458)
-0.16
(0.557)
-0.05
(0.296)
-0.12
(0.576)
-0.17
(0.750)
Basophils/Leukocytes: change at follow-up visit
-0.04
(0.360)
-0.15
(0.476)
-0.13
(0.443)
0.02
(0.512)
-0.25
(0.541)
-0.05
(0.449)
0.01
(0.472)
-0.25
(0.572)
Eosinophils/Leukocytes: change at week 1
-0.09
(1.390)
0.17
(1.840)
0.17
(0.934)
-0.37
(1.549)
-0.31
(1.607)
-0.19
(1.410)
0.89
(1.850)
-0.23
(1.339)
Eosinophils/Leukocytes: change at week 2
-0.11
(1.801)
-0.20
(1.298)
-0.16
(1.284)
0.11
(1.460)
-0.27
(1.131)
-0.14
(1.199)
0.16
(1.304)
-0.05
(1.531)
Eosinophils/Leukocytes: change at week 4
0.42
(1.982)
-0.12
(1.725)
0.15
(1.884)
-0.37
(1.729)
-0.35
(1.431)
-0.34
(1.258)
0.40
(1.468)
-0.37
(1.747)
Eosinophils/Leukocytes: change at week 6
-0.03
(1.522)
0.22
(1.570)
-0.04
(1.213)
0.02
(2.126)
-0.15
(1.714)
-0.01
(1.767)
0.05
(1.229)
-0.19
(1.840)
Eosinophils/Leukocytes: change at follow-up visit
0.16
(1.754)
-0.24
(1.860)
-0.09
(1.155)
-0.41
(2.188)
0.12
(1.954)
-0.05
(2.805)
0.50
(1.986)
-0.13
(2.021)
Monocytes/Leukocytes: change at week 1
0.02
(1.913)
0.12
(1.391)
0.50
(1.428)
-0.06
(1.409)
-0.01
(1.593)
-0.19
(1.043)
0.51
(1.275)
-0.11
(1.251)
Monocytes/Leukocytes: change at week 2
0.04
(2.055)
-0.31
(1.502)
0.30
(1.522)
-0.13
(1.267)
0.38
(1.362)
0.11
(1.318)
0.22
(1.414)
-0.01
(1.755)
Monocytes/Leukocytes : change at week 4
-0.51
(2.509)
-0.17
(1.966)
-0.02
(2.072)
-0.10
(1.582)
0.22
(1.323)
0.14
(1.323)
-0.03
(1.039)
0.33
(1.695)
Monocytes/Leukocytes : change at week 6
0.06
(2.488)
0.33
(2.257)
-0.00
(1.813)
-0.24
(1.217)
-0.12
(1.030)
0.13
(0.807)
-0.02
(1.324)
-0.16
(1.516)
Monocytes/Leukocytes : change at follow-up visit
0.06
(2.105)
-0.22
(1.304)
0.50
(1.463)
-0.07
(1.226)
0.13
(1.205)
0.26
(1.543)
0.15
(1.599)
-0.04
(1.047)
18. Secondary Outcome
Title Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 34 34 33 35 34
Erythrocytes: change at week 1
0.03
(0.261)
-0.07
(0.232)
-0.12
(0.264)
-0.04
(0.252)
-0.08
(0.254)
-0.08
(0.298)
-0.08
(0.192)
-0.09
(0.240)
Erythrocytes: change at week 2
-0.05
(0.234)
-0.03
(0.212)
-0.18
(0.251)
-0.10
(0.208)
-0.07
(0.242)
-0.10
(0.366)
-0.06
(0.229)
-0.11
(0.232)
Erythrocytes: change at week 4
-0.01
(0.216)
-0.05
(0.221)
-0.16
(0.251)
-0.10
(0.233)
0.01
(0.275)
-0.12
(0.271)
-0.08
(0.248)
-0.06
(0.219)
Erythrocytes: change at week 6
-0.04
(0.247)
-0.01
(0.180)
-0.17
(0.265)
-0.04
(0.238)
-0.02
(0.262)
-0.10
(0.256)
-0.07
(0.303)
-0.08
(0.239)
Erythrocytes: change at follow-up visit
0.03
(0.220)
0.02
(0.244)
-0.15
(0.266)
-0.03
(0.254)
0.04
(0.300)
-0.08
(0.280)
-0.03
(0.308)
-0.05
(0.262)
Reticulocytes: change at week 1
0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
0.0
(0.02)
0.0
(0.01)
0.0
(0.02)
-0.0
(0.02)
Reticulocytes: change at week 2
-0.0
(0.02)
0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
Reticulocytes: change at week 4
0.0
(0.03)
-0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
0.0
(0.02)
-0.0
(0.01)
-0.0
(0.02)
0.0
(0.02)
Reticulocytes: change at week 6
-0.0
(0.02)
0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
-0.0
(0.01)
-0.0
(0.02)
0.0
(0.02)
Reticulocytes: change at follow-up visit
-0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
-0.0
(0.02)
-0.0
(0.01)
-0.0
(0.02)
-0.0
(0.02)
0.0
(0.02)
19. Secondary Outcome
Title Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Description
Time Frame Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 34 35 33 34 34 33 35 34
Platelets: change at week 1
0.9
(60.03)
6.8
(34.08)
-3.3
(32.39)
1.0
(25.76)
8.5
(41.61)
6.6
(33.40)
-2.1
(31.94)
12.6
(44.08)
Platelets: change at week 2
-4.9
(58.16)
7.1
(43.34)
-8.1
(41.92)
-0.1
(32.45)
5.0
(31.39)
-4.9
(31.84)
7.5
(37.94)
14.8
(50.99)
Platelets: change at week 4
10.5
(36.42)
10.1
(37.55)
-2.4
(37.68)
-0.3
(36.27)
-5.9
(37.47)
4.4
(37.79)
0.7
(36.51)
11.0
(46.26)
Platelets: change at week 6
4.9
(35.17)
-3.3
(32.76)
-6.6
(41.66)
-2.3
(32.70)
-5.2
(38.53)
0.2
(37.28)
-1.8
(37.05)
8.6
(47.85)
Platelets: change at follow-up visit
1.3
(30.48)
16.3
(37.13)
-8.5
(30.15)
0.1
(32.36)
10.2
(47.30)
-5.2
(40.70)
5.8
(48.55)
2.5
(58.75)
Leukocytes: change at week 1
0.027
(1.8740)
0.395
(1.0940)
-0.051
(1.2403)
0.407
(1.2225)
0.259
(1.1290)
0.068
(1.2929)
0.238
(1.4993)
-0.025
(2.3529)
Leukocytes: change at week 2
-0.206
(1.8886)
0.459
(1.5567)
-0.288
(1.6842)
-0.094
(1.2877)
-0.116
(1.0364)
-0.007
(1.2637)
0.422
(1.8986)
-0.006
(2.3428)
Leukocytes: change at week 4
-0.203
(1.7390)
0.729
(1.3199)
0.189
(1.3534)
0.085
(1.3541)
-0.074
(1.0641)
0.398
(1.5999)
0.168
(1.0902)
0.041
(2.1647)
Leukocytes: change at week 6
0.160
(1.7059)
0.066
(1.0672)
-0.505
(1.6474)
0.237
(1.4501)
-0.244
(1.2763)
-0.269
(1.0761)
-0.048
(1.3823)
-0.347
(2.1442)
Leukocytes: change at follow-up visit
-0.066
(1.5744)
0.479
(1.0939)
-0.048
(2.0206)
0.329
(1.3938)
0.123
(0.8496)
-0.117
(1.4856)
0.210
(1.7456)
-0.404
(2.4817)
Lymphocytes: change at week 1
-0.008
(0.5539)
0.124
(0.3659)
0.107
(0.3130)
0.081
(0.3839)
0.186
(0.3840)
0.051
(0.3557)
0.089
(0.4320)
0.223
(0.3849)
Lymphocytes: change at week 2
-0.061
(0.5558)
0.145
(0.3735)
0.010
(0.4115)
0.044
(0.4225)
0.012
(0.4251)
-0.003
(0.3165)
0.070
(0.4603)
0.169
(0.5319)
Lymphocytes: change at week 4
0.107
(0.4302)
0.229
(0.3998)
0.135
(0.4400)
0.012
(0.4596)
0.139
(0.3977)
0.039
(0.4169)
0.127
(0.2630)
0.176
(0.6274)
Lymphocytes: change at week 6
0.033
(0.3375)
0.016
(0.3437)
-0.079
(0.4826)
0.104
(0.4337)
0.068
(0.3168)
-0.033
(0.3092)
0.027
(0.2455)
0.079
(0.3846)
Lymphocytes: change at follow-up visit
0.134
(0.3256)
0.194
(0.3533)
0.065
(0.6042)
-0.022
(0.4419)
0.130
(0.4277)
-0.035
(0.4054)
0.050
(0.4699)
0.195
(0.4663)
Neutrophils: change at week 1
0.027
(1.6137)
0.205
(0.9185)
-0.177
(1.0805)
0.319
(1.0276)
0.069
(1.0706)
0.017
(1.1291)
0.030
(1.3015)
-0.251
(2.2421)
Neutrophils: change at week 2
-0.119
(1.5672)
0.293
(1.5459)
-0.261
(1.3969)
-0.136
(1.0669)
-0.109
(0.9653)
-0.015
(1.1305)
0.288
(1.7822)
-0.190
(2.0749)
Neutrophils: change at week 4
-0.304
(1.6117)
0.441
(1.2814)
0.036
(1.1595)
0.096
(1.3199)
-0.190
(1.0404)
0.338
(1.3577)
-0.005
(0.9958)
-0.158
(2.0005)
Neutrophils: change at week 6
0.112
(1.6282)
-0.001
(0.8996)
-0.362
(1.3154)
0.112
(1.2240)
-0.250
(1.1720)
-0.228
(0.9681)
-0.064
(1.2422)
-0.376
(2.1125)
Neutrophils: change at follow-up visit
-0.229
(1.3379)
0.261
(0.8874)
-0.114
(1.4545)
0.343
(1.3049)
-0.020
(0.7731)
-0.093
(1.2340)
0.088
(1.4614)
-0.562
(2.3227)
Basophils: change at week 1
-0.006
(0.0319)
0.004
(0.0445)
-0.007
(0.0349)
0.010
(0.0258)
0.003
(0.0361)
0.001
(0.0191)
0.002
(0.0299)
0.002
(0.0343)
Basophils: change at week 2
-0.002
(0.0179)
0.004
(0.0261)
-0.009
(0.0276)
0.001
(0.0197)
-0.005
(0.0394)
0.003
(0.0244)
-0.003
(0.0433)
-0.012
(0.0428)
Basophils: change at week 4
-0.006
(0.0328)
0.011
(0.0404)
-0.002
(0.0300)
0.001
(0.0256)
-0.007
(0.0495)
-0.001
(0.0255)
-0.001
(0.0337)
-0.004
(0.0323)
Basophils: change at week 6
-0.005
(0.0186)
0.009
(0.0489)
-0.012
(0.0313)
0.008
(0.0344)
-0.015
(0.0415)
-0.004
(0.0188)
-0.009
(0.0373)
-0.015
(0.0383)
Basophils: change at follow-up visit
-0.004
(0.0265)
-0.003
(0.0259)
-0.007
(0.0321)
0.007
(0.0407)
-0.015
(0.0426)
-0.005
(0.0269)
0.001
(0.0295)
-0.019
(0.0361)
Eosinophils: change at week 1
0.007
(0.0964)
0.036
(0.0963)
-0.004
(0.1092)
-0.011
(0.0930)
-0.014
(0.1216)
-0.008
(0.1148)
0.068
(0.0959)
-0.006
(0.1165)
Eosinophils: change at week 2
-0.019
(0.1087)
-0.000
(0.0734)
-0.023
(0.0809)
0.009
(0.0980)
-0.029
(0.0915)
-0.006
(0.0621)
0.022
(0.0762)
0.005
(0.1256)
Eosinophils: change at week 4
0.032
(0.1813)
0.018
(0.1120)
0.008
(0.1325)
-0.019
(0.1102)
-0.032
(0.1040)
-0.012
(0.0832)
0.042
(0.1076)
-0.012
(0.1499)
Eosinophils: change at week 6
0.002
(0.0935)
0.029
(0.1090)
-0.025
(0.1351)
0.018
(0.1387)
-0.027
(0.1125)
-0.007
(0.1025)
-0.001
(0.0812)
-0.022
(0.1415)
Eosinophils: change at follow-up visit
0.022
(0.1461)
0.006
(0.0931)
-0.023
(0.1196)
-0.004
(0.1810)
0.008
(0.1270)
-0.008
(0.2483)
0.048
(0.1520)
-0.011
(0.1945)
Monocytes: change at week 1
0.006
(0.1796)
0.030
(0.0855)
0.030
(0.0987)
0.009
(0.0879)
0.019
(0.1055)
0.006
(0.0877)
0.051
(0.1244)
0.011
(0.1195)
Monocytes: change at week 2
-0.006
(0.1509)
0.016
(0.1343)
-0.003
(0.0724)
-0.014
(0.1055)
0.017
(0.0865)
0.013
(0.0983)
0.049
(0.1471)
0.025
(0.1496)
Monocytes: change at week 4
-0.035
(0.1904)
0.030
(0.1212)
0.013
(0.1234)
-0.003
(0.1092)
0.009
(0.0986)
0.035
(0.0978)
0.007
(0.1008)
0.038
(0.1331)
Monocytes: change at week 6
0.017
(0.1777)
0.017
(0.1069)
-0.025
(0.1191)
-0.005
(0.1021)
-0.019
(0.0726)
0.004
(0.0847)
0.003
(0.1097)
-0.012
(0.1200)
Monocytes: change at follow-up visit
0.011
(0.1806)
0.021
(0.0824)
0.030
(0.1467)
0.005
(0.0887)
0.021
(0.0739)
0.018
(0.1047)
0.029
(0.1788)
-0.006
(0.1282)
20. Secondary Outcome
Title Change From Baseline in Lipids Profile Values at Week 6
Description Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
Time Frame Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 28 27 31 32 29 24 30 32
HDL cholesterol
-2.8
(6.65)
0.1
(5.34)
-1.3
(7.74)
2.7
(8.33)
1.9
(11.18)
0.0
(6.76)
1.2
(4.12)
0.3
(8.56)
Triglycerides
3.3
(38.84)
-4.2
(59.30)
-6.5
(37.30)
1.8
(60.74)
-18.9
(56.78)
-8.1
(50.41)
-7.0
(58.36)
-4.4
(55.66)
Cholesterol
-3.5
(16.39)
-5.6
(27.59)
-12.8
(20.53)
6.8
(24.09)
-10.4
(30.79)
-0.2
(18.70)
5.3
(30.58)
-0.9
(19.86)
LDL Cholesterol
-3.4
(14.45)
-6.3
(25.28)
-12.1
(16.44)
2.1
(20.13)
-11.0
(29.06)
-0.8
(14.48)
4.4
(23.55)
-1.1
(16.29)
21. Secondary Outcome
Title Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Description Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
Time Frame Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 28 27 31 32 29 24 30 32
Mean (Standard Deviation) [Ratio]
0.0
(0.31)
-0.1
(0.48)
-0.2
(0.40)
-0.0
(0.32)
-0.3
(0.77)
-0.0
(0.35)
0.0
(0.46)
-0.0
(0.42)
22. Secondary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Description
Time Frame Baseline, Weeks 2 and 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Baseline
66.8
(11.45)
66.9
(9.33)
68.4
(14.66)
64.9
(9.05)
64.9
(12.26)
66.9
(12.03)
68.2
(12.11)
68.1
(12.48)
Change at week 2
0.7
(10.05)
-0.5
(8.03)
-1.8
(11.53)
-0.6
(7.88)
1.9
(8.01)
2.2
(8.76)
1.7
(9.13)
1.7
(12.52)
Change at week 6
0.3
(6.19)
-1.1
(7.65)
-1.7
(9.06)
0.8
(8.53)
-0.3
(8.46)
-0.8
(8.23)
0.5
(8.76)
-0.4
(12.06)
23. Secondary Outcome
Title Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Description
Time Frame Baseline, Weeks 2 and 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
PR interval: baseline
161.9
(23.30)
160.2
(24.01)
161.4
(27.59)
162.5
(22.04)
160.7
(24.20)
156.4
(22.65)
157.9
(23.55)
157.8
(23.15)
PR interval: change at week 2
0.8
(14.41)
-0.9
(15.92)
0.7
(18.54)
0.3
(10.13)
1.1
(14.42)
6.0
(14.79)
1.2
(16.06)
2.1
(7.98)
PR interval: change at week 6
-0.9
(10.16)
-0.1
(13.81)
2.8
(19.66)
2.9
(13.63)
3.5
(21.88)
4.0
(14.56)
6.5
(19.15)
5.7
(16.11)
QRS interval: baseline
92.5
(9.36)
91.5
(9.71)
91.1
(9.29)
93.0
(11.13)
93.1
(8.69)
92.2
(13.00)
92.4
(13.30)
91.5
(11.68)
QRS interval: change at week 2
-1.4
(8.02)
-0.4
(5.34)
-1.3
(3.46)
-0.8
(5.64)
0.1
(4.79)
1.5
(9.29)
0.2
(8.07)
1.0
(5.63)
QRS interval: change at week 6
-1.9
(6.55)
1.4
(5.62)
-0.5
(4.76)
-0.9
(4.04)
-1.3
(4.00)
0.9
(6.37)
0.6
(5.49)
0.7
(5.67)
QTCF interval: baseline
407.7
(17.78)
397.9
(15.98)
403.8
(22.43)
408.5
(18.42)
401.0
(16.29)
403.0
(16.65)
397.7
(17.05)
405.0
(20.38)
QTCF interval: change at week 2
-5.7
(11.86)
-1.5
(13.70)
-3.9
(15.60)
2.6
(16.20)
-0.6
(12.75)
1.4
(15.56)
2.4
(10.32)
-4.6
(15.43)
QTCF interval: change at week 6
-4.1
(14.61)
-0.5
(14.93)
-1.9
(14.37)
0.3
(17.19)
-1.4
(14.93)
4.6
(14.27)
2.0
(11.94)
-0.2
(9.67)
QT interval: baseline
395.2
(31.53)
385.3
(23.64)
388.8
(33.66)
401.0
(25.23)
392.0
(27.36)
390.9
(24.87)
383.8
(30.79)
390.6
(32.43)
QT interval: change at week 2
-5.9
(23.16)
-1.3
(17.73)
-1.1
(19.31)
3.5
(21.06)
-4.5
(15.75)
1.2
(24.03)
-2.3
(18.69)
-4.6
(25.76)
QT interval: change at week 6
-4.9
(19.54)
1.3
(18.11)
0.9
(16.11)
-4.1
(23.42)
-0.9
(20.12)
7.8
(24.11)
-1.4
(20.47)
4.0
(27.74)
24. Secondary Outcome
Title Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Description Blood pressure included supine and sitting systolic and diastolic BP.
Time Frame Baseline, Weeks 2 and 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 25 26 29 22 23 26 23 25
Supine systolic BP: Baseline
123.3
(12.01)
123.2
(12.35)
123.0
(13.89)
119.7
(9.08)
122.6
(12.76)
123.1
(12.40)
117.1
(14.07)
118.9
(12.43)
Supine systolic BP: change at week 2
0.3
(11.55)
-1.4
(9.61)
0.5
(14.73)
2.3
(6.99)
-0.3
(10.25)
-0.3
(8.02)
3.5
(13.65)
2.9
(8.48)
Supine systolic BP: change at week 6
-0.2
(12.98)
1.1
(10.06)
2.0
(14.05)
0.2
(9.13)
-3.4
(11.02)
-1.4
(10.49)
2.1
(12.41)
0.6
(10.31)
Sitting systolic BP: Baseline
117.7
(13.05)
120.8
(10.26)
120.2
(12.43)
116.9
(17.76)
124.6
(11.25)
119.4
(12.96)
122.9
(15.25)
125.6
(12.21)
Sitting systolic BP: change at week 2
1.3
(12.12)
-1.9
(11.86)
-3.9
(14.54)
1.3
(13.59)
-2.4
(11.76)
-3.1
(10.46)
1.1
(9.81)
4.4
(11.68)
Sitting systolic BP: change at week 6
0.6
(12.24)
-7.5
(8.67)
-9.4
(8.95)
1.0
(14.63)
-8.4
(10.81)
-0.6
(14.40)
-3.6
(8.37)
-1.5
(5.80)
Supine diastolic BP: Baseline
77.7
(9.28)
75.2
(8.79)
78.8
(8.39)
74.5
(8.26)
75.9
(8.78)
77.5
(8.71)
74.4
(8.20)
73.7
(8.59)
Supine diastolic BP: change at week 2
0.5
(7.51)
0.6
(6.47)
-0.4
(8.50)
1.6
(10.33)
1.2
(8.32)
-2.8
(6.69)
1.6
(8.89)
1.4
(7.74)
Supine diastolic BP: change at week 6
-2.5
(7.69)
1.5
(7.61)
-0.7
(8.32)
0.5
(7.96)
-0.9
(10.65)
-1.6
(6.22)
1.9
(9.72)
0.5
(6.32)
Sitting diastolic BP: Baseline
76.5
(9.28)
80.1
(6.76)
77.8
(10.02)
69.6
(11.48)
80.9
(8.21)
75.1
(5.77)
77.1
(12.00)
80.3
(7.83)
Sitting diastolic BP: change at week 2
-1.6
(8.49)
0.7
(7.93)
0.0
(9.44)
1.6
(12.00)
-2.9
(10.77)
1.7
(8.20)
4.5
(5.80)
-1.2
(6.49)
Sitting diastolic BP: change at week 6
0.8
(9.90)
0.0
(5.79)
-1.6
(11.97)
1.1
(15.61)
-5.3
(9.27)
-2.8
(12.60)
-0.3
(7.89)
0.4
(8.41)
25. Secondary Outcome
Title Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Description
Time Frame Baseline, Weeks 2 and 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Baseline
69.6
(12.58)
69.5
(9.82)
72.9
(14.30)
67.9
(9.31)
68.8
(11.76)
69.4
(11.15)
70.1
(11.18)
68.2
(9.59)
Change at week 2
0.5
(10.41)
0.2
(8.11)
-2.5
(9.66)
1.1
(9.13)
0.5
(6.54)
3.7
(9.47)
2.8
(8.28)
4.1
(9.16)
Change at week 6
2.1
(10.59)
0.3
(8.04)
-1.4
(11.90)
0.9
(9.71)
1.8
(8.73)
4.1
(6.76)
0.5
(9.12)
1.8
(8.64)
26. Secondary Outcome
Title Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Description
Time Frame Baseline, Weeks 2 and 6

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Baseline
36.5
(0.33)
36.5
(0.43)
36.6
(0.44)
36.6
(0.33)
36.5
(0.37)
36.5
(0.29)
36.6
(0.41)
36.6
(0.29)
Change at week 2
-0.1
(0.41)
-0.1
(0.30)
0.0
(0.38)
-0.0
(0.43)
0.1
(0.35)
-0.0
(0.38)
0.0
(0.34)
0.0
(0.41)
Change at week 6
-0.0
(0.40)
-0.0
(0.29)
0.0
(0.38)
0.1
(0.32)
0.0
(0.29)
0.1
(0.50)
0.0
(0.37)
-0.0
(0.46)
27. Secondary Outcome
Title Number of Participants With Each Severity Grade in Local Tolerability Assessments
Description Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.
Time Frame Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Measure Participants 37 37 36 37 36 36 36 37
Day 1: tolerability before: none
35
94.6%
35
94.6%
31
86.1%
33
89.2%
36
100%
35
97.2%
34
94.4%
36
97.3%
Day 1: tolerability before: mild
0
0%
0
0%
1
2.8%
3
8.1%
0
0%
1
2.8%
2
5.6%
0
0%
Day 1: tolerability before: moderate
2
5.4%
2
5.4%
4
11.1%
1
2.7%
0
0%
0
0%
0
0%
1
2.7%
Day 1: tolerability after: none
33
89.2%
36
97.3%
30
83.3%
33
89.2%
35
97.2%
34
94.4%
32
88.9%
33
89.2%
Day 1: tolerability after: mild
1
2.7%
0
0%
1
2.8%
2
5.4%
0
0%
2
5.6%
4
11.1%
1
2.7%
Day 1: tolerability after: moderate
1
2.7%
1
2.7%
3
8.3%
1
2.7%
0
0%
0
0%
0
0%
0
0%
Week 1: tolerability before: none
31
83.8%
28
75.7%
28
77.8%
30
81.1%
30
83.3%
30
83.3%
33
91.7%
33
89.2%
Week 1: tolerability before: mild
1
2.7%
2
5.4%
3
8.3%
3
8.1%
3
8.3%
1
2.8%
1
2.8%
1
2.7%
Week 1: tolerability before: moderate
2
5.4%
0
0%
3
8.3%
0
0%
0
0%
1
2.8%
0
0%
0
0%
Week 1: tolerability after: none
28
75.7%
29
78.4%
29
80.6%
30
81.1%
28
77.8%
27
75%
32
88.9%
31
83.8%
Week 1: tolerability after: mild
2
5.4%
2
5.4%
2
5.6%
3
8.1%
2
5.6%
3
8.3%
1
2.8%
1
2.7%
Week 1: tolerability after: moderate
2
5.4%
0
0%
2
5.6%
0
0%
0
0%
1
2.8%
0
0%
0
0%
Week 2: tolerability before: none
29
78.4%
28
75.7%
26
72.2%
30
81.1%
30
83.3%
23
63.9%
31
86.1%
33
89.2%
Week 2: tolerability before: mild
3
8.1%
2
5.4%
2
5.6%
2
5.4%
1
2.8%
1
2.8%
0
0%
0
0%
Week 2: tolerability before: moderate
1
2.7%
0
0%
3
8.3%
1
2.7%
0
0%
0
0%
1
2.8%
0
0%
Week 2: tolerability after: none
28
75.7%
26
70.3%
29
80.6%
31
83.8%
29
80.6%
23
63.9%
32
88.9%
30
81.1%
Week 2: tolerability after: mild
1
2.7%
3
8.1%
2
5.6%
1
2.7%
1
2.8%
2
5.6%
0
0%
1
2.7%
Week 2: tolerability after: moderate
1
2.7%
0
0%
1
2.8%
1
2.7%
0
0%
0
0%
1
2.8%
0
0%
Week 4: tolerability before: none
27
73%
26
70.3%
30
83.3%
30
81.1%
30
83.3%
24
66.7%
31
86.1%
31
83.8%
Week 4: tolerability before: mild
0
0%
2
5.4%
2
5.6%
2
5.4%
0
0%
0
0%
1
2.8%
1
2.7%
Week 4: tolerability before: moderate
1
2.7%
0
0%
1
2.8%
0
0%
1
2.8%
1
2.8%
0
0%
0
0%
Week 4: tolerability after: none
24
64.9%
26
70.3%
30
83.3%
30
81.1%
29
80.6%
24
66.7%
31
86.1%
30
81.1%
Week 4: tolerability after: mild
1
2.7%
2
5.4%
2
5.6%
1
2.7%
0
0%
0
0%
1
2.8%
0
0%
Week 4: tolerability after: moderate
1
2.7%
0
0%
0
0%
0
0%
1
2.8%
1
2.8%
0
0%
0
0%
Week 6: tolerability before: none
26
70.3%
25
67.6%
29
80.6%
30
81.1%
30
83.3%
21
58.3%
30
83.3%
32
86.5%
Week 6: tolerability before: mild
1
2.7%
1
2.7%
2
5.6%
1
2.7%
0
0%
1
2.8%
0
0%
1
2.7%
Week 6: tolerability before: moderate
0
0%
0
0%
2
5.6%
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
Week 6: tolerability after: none
25
67.6%
24
64.9%
28
77.8%
29
78.4%
29
80.6%
22
61.1%
30
83.3%
30
81.1%
Week 6: tolerability after: mild
0
0%
1
2.7%
3
8.3%
0
0%
0
0%
0
0%
0
0%
0
0%
Week 6: tolerability after: moderate
0
0%
0
0%
1
2.8%
1
2.7%
0
0%
1
2.8%
0
0%
0
0%
Early termination:tolerability: none
6
16.2%
5
13.5%
3
8.3%
2
5.4%
2
5.6%
9
25%
2
5.6%
1
2.7%
Early termination:tolerability: mild
0
0%
2
5.4%
0
0%
0
0%
0
0%
0
0%
0
0%
1
2.7%
Early termination:tolerability: moderate
2
5.4%
0
0%
0
0%
0
0%
0
0%
1
2.8%
0
0%
0
0%
Early termination:tolerability: severe
1
2.7%
1
2.7%
0
0%
1
2.7%
1
2.8%
0
0%
0
0%
0
0%
Follow Up: tolerability: none
22
59.5%
26
70.3%
25
69.4%
25
67.6%
28
77.8%
25
69.4%
26
72.2%
28
75.7%
Follow Up: tolerability: mild
1
2.7%
0
0%
2
5.6%
0
0%
0
0%
1
2.8%
1
2.8%
1
2.7%
Follow Up: tolerability: moderate
1
2.7%
0
0%
1
2.8%
4
10.8%
1
2.8%
1
2.8%
0
0%
0
0%
Follow Up: tolerability: severe
0
0%
0
0%
1
2.8%
0
0%
0
0%
0
0%
0
0%
0
0%

Adverse Events

Time Frame Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Adverse Event Reporting Description
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
All Cause Mortality
Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Serious Adverse Events
Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Other (Not Including Serious) Adverse Events
Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 18/37 (48.6%) 17/37 (45.9%) 11/36 (30.6%) 12/37 (32.4%) 10/36 (27.8%) 17/36 (47.2%) 9/36 (25%) 14/37 (37.8%)
Eye disorders
Swelling of eyelid 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Ulcerative keratitis 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Gastrointestinal disorders
Dyspepsia 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Nausea 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
General disorders
Administration site warmth 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Application site acne 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Application site erythema 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 1/37 (2.7%)
Application site pain 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 1/37 (2.7%)
Application site pruritus 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 3/36 (8.3%) 0/36 (0%) 0/37 (0%)
Chills 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Injection site pain 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Oedema peripheral 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Pain 1/37 (2.7%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Pyrexia 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Vessel puncture site haematoma 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Immune system disorders
Allergy to arthropod sting 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Cockroach allergy 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Mite allergy 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Allergy to animal 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Infections and infestations
Bacterial allergy 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Bronchitis 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Conjunctivitis 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Cystitis 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Eczema infected 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Folliculitis 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 1/37 (2.7%)
Furuncle 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Gastroenteritis 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Gastroenteritis viral 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Gingivitis 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Herpes simplex 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Influenza 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 2/37 (5.4%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Kaposi's varicelliform eruption 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Laryngitis 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Nasopharyngitis 1/37 (2.7%) 2/37 (5.4%) 2/36 (5.6%) 3/37 (8.1%) 4/36 (11.1%) 2/36 (5.6%) 2/36 (5.6%) 2/37 (5.4%)
Oral herpes 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Pharyngitis 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Rhinitis 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Skin infection 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Staphylococcal skin infection 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Tonsillitis 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Upper respiratory tract infection 0/37 (0%) 1/37 (2.7%) 1/36 (2.8%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Urinary tract infection 1/37 (2.7%) 0/37 (0%) 2/36 (5.6%) 2/37 (5.4%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Vaginal infection 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Viral infection 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Viral pharyngitis 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Viral rhinitis 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Viral upper respiratory tract infection 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 1/37 (2.7%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Injury, poisoning and procedural complications
Limb injury 1/37 (2.7%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Tooth fracture 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Investigations
Alanine aminotransferase increased 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Aspartate aminotransferase increased 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Blood bilirubin increased 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Blood creatine phosphokinase increased 0/37 (0%) 1/37 (2.7%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Blood glucose increased 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Electrocardiogram T wave inversion 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Glomerular filtration rate decreased 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Lipids abnormal 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Neutrophil count decreased 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Pregnancy test positive 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Musculoskeletal and connective tissue disorders
Back pain 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Musculoskeletal pain 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Neck pain 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Nervous system disorders
Burning sensation 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Headache 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Psychiatric disorders
Insomnia 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Renal and urinary disorders
Dysuria 0/37 (0%) 0/37 (0%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Reproductive system and breast disorders
Menstruation irregular 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Metrorrhagia 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/37 (0%) 0/37 (0%) 2/36 (5.6%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/37 (0%)
Increased viscosity of bronchial secretion 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Oropharyngeal pain 1/37 (2.7%) 2/37 (5.4%) 1/36 (2.8%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Skin and subcutaneous tissue disorders
Acne 0/37 (0%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Dermatitis atopic 3/37 (8.1%) 3/37 (8.1%) 1/36 (2.8%) 0/37 (0%) 1/36 (2.8%) 3/36 (8.3%) 0/36 (0%) 2/37 (5.4%)
Dermatitis contact 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 1/37 (2.7%)
Dry skin 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Eczema 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/37 (0%)
Erythema 1/37 (2.7%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 1/37 (2.7%)
Granuloma annulare 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/37 (2.7%)
Hyperhidrosis 0/37 (0%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/37 (0%)
Photosensitivity reaction 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Pruritus 2/37 (5.4%) 1/37 (2.7%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Skin discolouration 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Skin irritation 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/37 (0%)
Solar urticaria 0/37 (0%) 0/37 (0%) 0/36 (0%) 1/37 (2.7%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)
Vascular disorders
Haematoma 1/37 (2.7%) 0/37 (0%) 0/36 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03903822
Other Study ID Numbers:
  • B7931022
  • 2018-003050-24
First Posted:
Apr 4, 2019
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021