Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02969018
Collaborator
(none)
212
44
8
14.9
4.8
0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06700841 60 mg followed by 30 mg once daily

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily

Drug: PF-06700841

Experimental: PF-06700841 60 mg followed by 10 mg once daily

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

Drug: PF-06700841

Experimental: PF-06700841 60mg once daily followed by 100mg once weekly

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

Drug: PF-06700841

Experimental: PF-06700841 60mg once daily followed by placebo once daily

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily

Drug: PF-06700841

Experimental: PF-06700841 30mg once daily

4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily

Drug: PF-06700841

Experimental: PF-06700841 30mg once daily followed by 10mg once daily

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

Drug: PF-06700841

Experimental: PF-06700841 30mg once daily followed by 100mg once weekly

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

Drug: PF-06700841

Placebo Comparator: Placebo

12 weeks once daily placebo

Other: Placebo

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [Baseline (Day 1 pre-dose), Week 12]

    The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Secondary Outcome Measures

  1. Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 [Week 12]

    A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  2. Change From Baseline in PASI Scores at Week 4 by Induction Dose [Baseline (Day 1 pre-dose), Week 4]

    Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  3. Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 14, 16]

    A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  4. Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]

    A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  5. Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]

    A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  6. Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 [Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16]

    The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  7. Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]

    The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

  8. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [From first dose of study treatment (Day 1) up to Week 20]

    An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

  9. Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs [From first dose of study treatment (Day 1) up to Week 20]

    The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).

  10. Change From Baseline in Blood Lipid Level at Weeks 4 and 12 [Baseline (Day 1 pre-dose), Weeks 4 and 12]

    Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

  11. Number of Participants With Any Post-Baseline Laboratory Test Abnormalities [From first dose of study treatment (Day 1) up to Week 16]

    Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).

  12. Number of Participants With Post-Baseline Vital Sign Abnormalities [From first dose of study treatment (Day 1) up to Week 16]

    Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.

  13. Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities [From first dose of study treatment (Day 1) up to Week 16]

    ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)

  • Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)

  • Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)

  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:
  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed

  • Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis

  • Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)

  • Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).

  • Have taken Apremilast (Otezla) within 3 months of first dose of study drug.

  • Have undergone treatment with tofacitinib within 3 months of first dose.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA Rogers Arkansas United States 72758
2 Anaheim Clinical Trials, LLC Anaheim California United States 92801
3 California Dermatology & Clinical Research Institute Encinitas California United States 92024
4 Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery Sacramento California United States 95819
5 Southern California Dermatology Santa Ana California United States 92701
6 Tower Saint John's Imaging Santa Monica California United States 90403
7 Clinical Science Institute Santa Monica California United States 90404
8 Park Avenue Dermatology Administrative Annex Orange Park Florida United States 32073
9 Park Avenue Dermatology Orange Park Florida United States 32073
10 Olympian Clinical Research Tampa Florida United States 33609
11 Rose Radiology Tampa Florida United States 33609
12 Forward Clinical Trials, Inc Tampa Florida United States 33624
13 Dundee Dermatology West Dundee Illinois United States 60118
14 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46256
15 Dawes Fretzin Dermatology Group, LLC Indianapolis Indiana United States 46256
16 Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
17 The Rockefeller University New York New York United States 10065
18 Skin Search of Rochester, Inc. Rochester New York United States 14623
19 Investigational Drug Services, UNC Hospitals Chapel Hill North Carolina United States 27514
20 UNC Dermatology and Skin Cancer Center Chapel Hill North Carolina United States 27516
21 UNC Clinical and Translation Research Center Chapel Hill North Carolina United States 27599
22 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
23 Vital Prospects Clinical Research Institute, P.C Tulsa Oklahoma United States 74136
24 Health Concepts Rapid City South Dakota United States 57702
25 Center for Clinical Studies Houston Texas United States 77004
26 Lee Medical Associates, PA San Antonio Texas United States 78213
27 Progressive Clinical Research, PA San Antonio Texas United States 78213
28 Texas Dermatology and Laser Specialists San Antonio Texas United States 78218
29 Virginia Clinical Research, Inc. Norfolk Virginia United States 23502
30 Premier Clinical Research Spokane Washington United States 99202
31 Wiseman Dermatology Research Inc. Winnipeg Manitoba Canada R3M 3Z4
32 Lynderm Research Inc Markham Ontario Canada L3P 1X2
33 Research by ICLS Oakville Ontario Canada L6J 7W5
34 Skin Centre for Dermatology Peterborough Ontario Canada K9J 5K2
35 The Centre for Dermatology Richmond Hill Ontario Canada L4B 1A5
36 K.Papp Clinical Research Inc. Waterloo Ontario Canada N2J 1C4
37 Diex Research Sherbrooke Inc. Sherbrooke Quebec Canada J1L 0H8
38 Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) Quebec Canada G1V4X7
39 Centrum Medyczne Enel-Med Przychodnia Grunwaldzka Gdansk Poland 80-266
40 Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk Poland 80-546
41 Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak Lodz Poland 90-436
42 NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna Torun Poland 87-100
43 MTZ Clinical Research Sp. z o.o. Warszawa Poland 02-106
44 WroMedica 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:
NCT02969018
Other Study ID Numbers:
  • B7931004
  • 2016-004049-96
First Posted:
Nov 21, 2016
Last Update Posted:
Mar 29, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Period Title: Overall Study
STARTED 25 29 26 25 29 25 30 23
COMPLETED 21 21 20 20 27 17 22 16
NOT COMPLETED 4 8 6 5 2 8 8 7

Baseline Characteristics

Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo Total
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets. Total of all reporting groups
Overall Participants 25 29 26 25 29 25 30 23 212
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
49.0
(14.69)
44.6
(13.71)
45.5
(12.93)
48.4
(15.47)
44.2
(10.92)
44.0
(11.56)
43.2
(12.28)
50.3
(12.23)
46.0
(13.04)
Age, Customized (Count of Participants)
18-44 Years
8
32%
14
48.3%
10
38.5%
8
32%
14
48.3%
12
48%
14
46.7%
8
34.8%
88
41.5%
45-64 Years
14
56%
13
44.8%
14
53.8%
13
52%
14
48.3%
13
52%
16
53.3%
12
52.2%
109
51.4%
>=65 Years
3
12%
2
6.9%
2
7.7%
4
16%
1
3.4%
0
0%
0
0%
3
13%
15
7.1%
Sex: Female, Male (Count of Participants)
Female
9
36%
8
27.6%
14
53.8%
4
16%
10
34.5%
8
32%
7
23.3%
4
17.4%
64
30.2%
Male
16
64%
21
72.4%
12
46.2%
21
84%
19
65.5%
17
68%
23
76.7%
19
82.6%
148
69.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
16%
4
13.8%
4
15.4%
2
8%
6
20.7%
5
20%
4
13.3%
4
17.4%
33
15.6%
Not Hispanic or Latino
21
84%
25
86.2%
22
84.6%
23
92%
23
79.3%
20
80%
26
86.7%
19
82.6%
179
84.4%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
White
22
88%
27
93.1%
23
88.5%
24
96%
27
93.1%
22
88%
25
83.3%
19
82.6%
189
89.2%
Black or African American
3
12%
0
0%
3
11.5%
0
0%
1
3.4%
1
4%
1
3.3%
2
8.7%
11
5.2%
Asian
0
0%
1
3.4%
0
0%
1
4%
0
0%
0
0%
2
6.7%
0
0%
4
1.9%
American Indian or Alaska Native
0
0%
1
3.4%
0
0%
0
0%
0
0%
1
4%
0
0%
1
4.3%
3
1.4%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
1
4%
1
3.3%
0
0%
2
0.9%
Other
0
0%
0
0%
0
0%
0
0%
1
3.4%
0
0%
1
3.3%
1
4.3%
3
1.4%

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Week 12

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for Week 12.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 22 21 21 21 27 19 25 17
Least Squares Mean (90% Confidence Interval) [units on a scale]
-15.85
-10.56
-14.28
-10.14
-17.28
-13.27
-11.88
-7.21
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0005
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -8.64
Confidence Interval (2-Sided) 90%
-12.33 to -4.95
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.232
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 10 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0963
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.34
Confidence Interval (2-Sided) 90%
-6.99 to 0.30
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.206
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0046
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.07
Confidence Interval (2-Sided) 90%
-10.76 to -3.37
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.233
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by Placebo, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0963
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.93
Confidence Interval (2-Sided) 90%
-6.63 to 0.77
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.238
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -10.07
Confidence Interval (2-Sided) 90%
-13.63 to -6.51
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.152
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 10 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0158
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -6.06
Confidence Interval (2-Sided) 90%
-9.79 to -2.33
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.255
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 100 mg QW, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.0488
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.66
Confidence Interval (2-Sided) 90%
-8.24 to -1.09
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.163
Estimation Comments
2. Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
Description A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data at Week 12 after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Number (90% Confidence Interval) [percentage of participants]
60.0
240%
24.1
83.1%
57.7
221.9%
24.0
96%
86.2
297.2%
24.0
96%
36.7
122.3%
13.0
56.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.00
Confidence Interval (2-Sided) 90%
2.95 to 33.87
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 10 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.12
Confidence Interval (2-Sided) 90%
0.61 to 7.36
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.09
Confidence Interval (2-Sided) 90%
2.71 to 30.48
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by Placebo, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
0.59 to 7.55
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 41.67
Confidence Interval (2-Sided) 90%
10.80 to 160.68
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 10 mg QD, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
0.59 to 7.55
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 100 mg QW, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.86
Confidence Interval (2-Sided) 90%
1.17 to 12.74
Parameter Dispersion Type:
Value:
Estimation Comments
Other Statistical Analysis Logistic regression
3. Secondary Outcome
Title Change From Baseline in PASI Scores at Week 4 by Induction Dose
Description Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Week 4

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data at Week 4.
Arm/Group Title PF-06700841 60 mg QD as the Induction Dose PF-06700841 30 mg QD as the Induction Dose Placebo as the Induction Dose
Arm/Group Description Participants received PF-06700841 60 mg QD as the induction dose. Participants received PF-06700841 30 mg QD as the induction dose. Participants received matching placebo QD as the induction dose.
Measure Participants 100 81 21
Least Squares Mean (90% Confidence Interval) [units on a scale]
-13.17
-12.16
-4.17
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.00
Confidence Interval (2-Sided) 90%
-11.43 to -6.57
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.470
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 10 mg QD, PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.99
Confidence Interval (2-Sided) 90%
-10.48 to -5.51
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.502
Estimation Comments
4. Secondary Outcome
Title Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Description A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 14, 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Week 1
0
0%
6.9
23.8%
7.7
29.6%
4.0
16%
0
0%
4.0
16%
0
0%
0
0%
Week 2
8.0
32%
13.8
47.6%
26.9
103.5%
12.0
48%
3.4
11.7%
8.0
32%
0
0%
0
0%
Week 4
24.0
96%
41.4
142.8%
61.5
236.5%
36.0
144%
27.6
95.2%
24.0
96%
36.7
122.3%
0
0%
Week 6
44.0
176%
41.4
142.8%
65.4
251.5%
36.0
144%
51.7
178.3%
28.0
112%
26.7
89%
8.7
37.8%
Week 8
60.0
240%
37.9
130.7%
65.4
251.5%
32.0
128%
65.5
225.9%
20.0
80%
40.0
133.3%
8.7
37.8%
Week 10
48.0
192%
24.1
83.1%
61.5
236.5%
32.0
128%
72.4
249.7%
28.0
112%
46.7
155.7%
13.0
56.5%
Week 14
48.0
192%
17.2
59.3%
34.6
133.1%
16.0
64%
75.9
261.7%
16.0
64%
16.7
55.7%
8.7
37.8%
Week 16
36.0
144%
10.3
35.5%
30.8
118.5%
20.0
80%
58.6
202.1%
12.0
48%
16.7
55.7%
8.7
37.8%
5. Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Week 1
12.0
48%
13.8
47.6%
19.2
73.8%
20.0
80%
10.3
35.5%
8.0
32%
3.3
11%
0
0%
Week 2
44.0
176%
37.9
130.7%
46.2
177.7%
32.0
128%
41.4
142.8%
20.0
80%
33.3
111%
0
0%
Week 4
60.0
240%
69.0
237.9%
69.2
266.2%
68.0
272%
69.0
237.9%
60.0
240%
66.7
222.3%
13.0
56.5%
Week 6
72.0
288%
62.1
214.1%
73.1
281.2%
68.0
272%
82.8
285.5%
60.0
240%
63.3
211%
26.1
113.5%
Week 8
72.0
288%
55.2
190.3%
73.1
281.2%
52.0
208%
86.2
297.2%
56.0
224%
63.3
211%
17.4
75.7%
Week 10
68.0
272%
44.8
154.5%
73.1
281.2%
48.0
192%
86.2
297.2%
48.0
192%
56.7
189%
17.4
75.7%
Week 12
68.0
272%
44.8
154.5%
69.2
266.2%
52.0
208%
89.7
309.3%
48.0
192%
53.3
177.7%
21.7
94.3%
Week 14
64.0
256%
44.8
154.5%
61.5
236.5%
48.0
192%
89.7
309.3%
36.0
144%
36.7
122.3%
26.1
113.5%
Week 16
60.0
240%
34.5
119%
53.8
206.9%
40.0
160%
79.3
273.4%
40.0
160%
36.7
122.3%
21.7
94.3%
6. Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Week 1
0
0%
3.4
11.7%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Week 2
0
0%
3.4
11.7%
7.7
29.6%
0
0%
0
0%
0
0%
0
0%
0
0%
Week 4
12.0
48%
20.7
71.4%
42.3
162.7%
16.0
64%
6.9
23.8%
8.0
32%
3.3
11%
0
0%
Week 6
16.0
64%
20.7
71.4%
26.9
103.5%
12.0
48%
24.1
83.1%
8.0
32%
20.0
66.7%
0
0%
Week 8
24.0
96%
17.2
59.3%
30.8
118.5%
8.0
32%
34.5
119%
4.0
16%
16.7
55.7%
0
0%
Week 10
28.0
112%
17.2
59.3%
26.9
103.5%
8.0
32%
34.5
119%
8.0
32%
13.3
44.3%
4.3
18.7%
Week 12
36.0
144%
13.8
47.6%
26.9
103.5%
8.0
32%
51.7
178.3%
8.0
32%
10.0
33.3%
4.3
18.7%
Week 14
28.0
112%
13.8
47.6%
11.5
44.2%
8.0
32%
37.9
130.7%
4.0
16%
13.3
44.3%
4.3
18.7%
Week 16
20.0
80%
3.4
11.7%
15.4
59.2%
4.0
16%
27.6
95.2%
8.0
32%
10.0
33.3%
4.3
18.7%
7. Secondary Outcome
Title Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Description The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Week 1
-5.74
-4.60
-5.85
-5.37
-3.97
-4.41
-3.46
-1.35
Week 2
-9.44
-8.35
-10.79
-9.49
-7.86
-7.79
-7.93
-2.28
Week 4
-12.85
-12.19
-14.11
-13.91
-11.72
-12.88
-13.06
-4.02
Week 6
-15.00
-12.12
-15.00
-13.85
-14.30
-14.33
-14.17
-5.52
Week 8
-15.94
-11.09
-14.97
-12.87
-15.82
-14.27
-13.83
-6.56
Week 10
-16.54
-9.89
-15.52
-11.64
-16.65
-14.98
-12.97
-6.78
Week 14
-15.47
-8.11
-13.31
-9.45
-16.14
-10.44
-11.03
-6.98
Week 16
-14.16
-6.59
-13.00
-7.83
-14.38
-9.62
-9.13
-6.76
8. Secondary Outcome
Title Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Week 1
-26.70
-24.66
-30.25
-23.33
-20.92
-17.50
-15.42
-6.90
Week 2
-43.66
-44.17
-54.27
-42.58
-40.89
-32.46
-35.89
-12.81
Week 4
-57.16
-63.02
-72.41
-64.71
-60.76
-53.93
-58.99
-25.17
Week 6
-66.07
-63.31
-75.96
-65.06
-73.91
-58.57
-63.17
-33.49
Week 8
-70.11
-62.25
-77.05
-59.88
-81.04
-58.32
-61.38
-37.76
Week 10
-70.72
-57.55
-78.46
-53.81
-84.82
-61.23
-57.24
-39.68
Week 12
-71.94
-58.52
-74.42
-51.49
-88.68
-57.81
-58.57
-40.27
Week 14
-64.15
-47.87
-63.20
-44.30
-83.39
-47.84
-47.52
-39.48
Week 16
-57.28
-38.48
-60.56
-36.63
-74.18
-44.58
-42.29
-38.79
9. Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time Frame From first dose of study treatment (Day 1) up to Week 20

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Treatment-emergent AEs
19
76%
21
72.4%
18
69.2%
18
72%
21
72.4%
16
64%
23
76.7%
13
56.5%
Treatment-emergent SAEs
2
8%
1
3.4%
1
3.8%
1
4%
0
0%
0
0%
0
0%
0
0%
10. Secondary Outcome
Title Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
Description The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
Time Frame From first dose of study treatment (Day 1) up to Week 20

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
Count of Participants [Participants]
2
8%
4
13.8%
1
3.8%
2
8%
0
0%
2
8%
2
6.7%
0
0%
11. Secondary Outcome
Title Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Description Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Time Frame Baseline (Day 1 pre-dose), Weeks 4 and 12

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had data for each specified category.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 26 25 29 25 30 23
LDL Cholesterol, Week 4
15.91
11.27
15.00
15.88
8.96
-2.21
7.60
-6.28
LDL Cholesterol, Week 12
8.71
6.00
-0.74
6.85
14.10
-5.33
3.95
-4.00
HDL Cholesterol, Week 4
12.09
9.14
10.92
8.58
6.36
6.76
9.39
0.00
HDL Cholesterol, Week 12
5.00
5.48
2.48
-0.24
4.74
4.37
2.88
-2.73
Total Cholesterol, Week 4
34.39
29.46
31.32
26.33
15.14
10.36
14.00
-4.42
Total Cholesterol, Week 12
19.50
15.67
-1.86
7.05
20.37
0.68
4.33
-6.40
Triglycerides, Week 4
34.74
29.68
8.04
8.92
-65.11
19.60
-59.75
15.26
Triglycerides, Week 12
27.86
48.33
-85.00
2.67
-18.96
6.32
-67.79
1.87
12. Secondary Outcome
Title Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).
Time Frame From first dose of study treatment (Day 1) up to Week 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline laboratory data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 25 25 28 25 30 23
Count of Participants [Participants]
17
68%
20
69%
20
76.9%
16
64%
21
72.4%
20
80%
18
60%
11
47.8%
13. Secondary Outcome
Title Number of Participants With Post-Baseline Vital Sign Abnormalities
Description Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Time Frame From first dose of study treatment (Day 1) up to Week 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline vital signs data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 25 29 25 25 28 25 30 23
Sitting DBP <50 mm Hg
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Sitting DBP increase >=20 mm Hg
1
4%
1
3.4%
3
11.5%
2
8%
0
0%
0
0%
0
0%
0
0%
Sitting DBP decrease >=20 mm Hg
3
12%
0
0%
2
7.7%
2
8%
1
3.4%
2
8%
2
6.7%
1
4.3%
Sitting SBP <90 mm Hg
1
4%
1
3.4%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Sitting SBP increase >=30 mm Hg
1
4%
3
10.3%
2
7.7%
1
4%
0
0%
1
4%
0
0%
0
0%
Sitting SBP decrease >=30 mm Hg
2
8%
2
6.9%
1
3.8%
2
8%
1
3.4%
3
12%
2
6.7%
1
4.3%
Sitting pulse rate <40 bpm
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Sitting pulse rate >120 bpm
0
0%
0
0%
0
0%
0
0%
0
0%
1
4%
0
0%
0
0%
14. Secondary Outcome
Title Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Description ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.
Time Frame From first dose of study treatment (Day 1) up to Week 16

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline ECG data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Measure Participants 24 29 25 25 28 25 28 22
PR interval >=300 msec
0
0%
0
0%
1
3.8%
0
0%
1
3.4%
0
0%
0
0%
0
0%
%Change in PR interval >=25/50%
0
0%
0
0%
0
0%
0
0%
0
0%
1
4%
0
0%
0
0%
QRS duration >=140 msec
0
0%
1
3.4%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
%Change in QRS duration >=50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
3.3%
0
0%
QT interval >=500 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
QTc >=450 to <480 msec
6
24%
1
3.4%
2
7.7%
0
0%
1
3.4%
1
4%
0
0%
1
4.3%
QTc >=480 to <500 msec
0
0%
0
0%
1
3.8%
0
0%
0
0%
0
0%
0
0%
1
4.3%
QTc >=500 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
QTc change >=30 to <60 msec
2
8%
0
0%
2
7.7%
1
4%
3
10.3%
3
12%
0
0%
1
4.3%
QTc change >=60 msec
0
0%
0
0%
2
7.7%
0
0%
0
0%
0
0%
0
0%
1
4.3%

Adverse Events

Time Frame From first dose of study treatment up to 20 weeks
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
All Cause Mortality
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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 1/25 (4%) 0/29 (0%) 0/26 (0%) 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/30 (0%) 0/23 (0%)
Serious Adverse Events
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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 2/25 (8%) 1/29 (3.4%) 1/26 (3.8%) 1/25 (4%) 0/29 (0%) 0/25 (0%) 0/30 (0%) 0/23 (0%)
Blood and lymphatic system disorders
Anaemia 0/25 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/25 (0%) 0 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Cardiac disorders
Angina pectoris 1/25 (4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/25 (0%) 0 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
General disorders
Chest pain 0/25 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 1/25 (4%) 1 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Infections and infestations
Pneumonia 0/25 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/25 (0%) 0 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Sepsis 0/25 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/25 (0%) 0 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Injury, poisoning and procedural complications
Gun shot wound 1/25 (4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/25 (0%) 0 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Other (Not Including Serious) Adverse Events
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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 11/25 (44%) 14/29 (48.3%) 13/26 (50%) 13/25 (52%) 13/29 (44.8%) 12/25 (48%) 16/30 (53.3%) 9/23 (39.1%)
Gastrointestinal disorders
Diarrhoea 0/25 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 1/25 (4%) 1 0/29 (0%) 0 1/25 (4%) 1 3/30 (10%) 4 1/23 (4.3%) 1
Nausea 1/25 (4%) 1 1/29 (3.4%) 1 1/26 (3.8%) 1 2/25 (8%) 2 0/29 (0%) 0 0/25 (0%) 0 1/30 (3.3%) 1 2/23 (8.7%) 2
Cheilitis 0/25 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/25 (0%) 0 2/29 (6.9%) 2 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Vomiting 0/25 (0%) 0 1/29 (3.4%) 1 1/26 (3.8%) 1 1/25 (4%) 1 0/29 (0%) 0 2/25 (8%) 2 0/30 (0%) 0 0/23 (0%) 0
General disorders
Fatigue 1/25 (4%) 1 1/29 (3.4%) 1 1/26 (3.8%) 1 2/25 (8%) 2 0/29 (0%) 0 1/25 (4%) 1 0/30 (0%) 0 1/23 (4.3%) 1
Infections and infestations
Upper respiratory tract infection 2/25 (8%) 2 1/29 (3.4%) 1 5/26 (19.2%) 5 1/25 (4%) 1 2/29 (6.9%) 2 0/25 (0%) 0 3/30 (10%) 3 1/23 (4.3%) 1
Bronchitis 0/25 (0%) 0 2/29 (6.9%) 2 0/26 (0%) 0 0/25 (0%) 0 2/29 (6.9%) 2 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Nasopharyngitis 4/25 (16%) 4 3/29 (10.3%) 4 3/26 (11.5%) 3 3/25 (12%) 3 5/29 (17.2%) 6 6/25 (24%) 6 4/30 (13.3%) 5 3/23 (13%) 3
Sinusitis 1/25 (4%) 1 0/29 (0%) 0 1/26 (3.8%) 2 2/25 (8%) 2 0/29 (0%) 0 0/25 (0%) 0 1/30 (3.3%) 1 0/23 (0%) 0
Urinary tract infection 0/25 (0%) 0 1/29 (3.4%) 1 1/26 (3.8%) 1 0/25 (0%) 0 0/29 (0%) 0 1/25 (4%) 1 2/30 (6.7%) 2 0/23 (0%) 0
Injury, poisoning and procedural complications
Ligament sprain 0/25 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/25 (0%) 0 0/29 (0%) 0 2/25 (8%) 2 0/30 (0%) 0 0/23 (0%) 0
Investigations
Neutrophil count decreased 0/25 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/25 (0%) 0 2/29 (6.9%) 2 0/25 (0%) 0 1/30 (3.3%) 1 0/23 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 1/25 (4%) 1 2/29 (6.9%) 2 0/26 (0%) 0 0/25 (0%) 0 2/29 (6.9%) 2 2/25 (8%) 2 1/30 (3.3%) 2 2/23 (8.7%) 2
Arthralgia 1/25 (4%) 3 2/29 (6.9%) 2 0/26 (0%) 0 0/25 (0%) 0 1/29 (3.4%) 1 1/25 (4%) 1 1/30 (3.3%) 1 1/23 (4.3%) 1
Nervous system disorders
Headache 1/25 (4%) 1 2/29 (6.9%) 2 3/26 (11.5%) 3 3/25 (12%) 3 4/29 (13.8%) 6 1/25 (4%) 1 0/30 (0%) 0 1/23 (4.3%) 1
Psychiatric disorders
Irritability 0/25 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 2/25 (8%) 2 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 0/25 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/25 (0%) 0 2/29 (6.9%) 2 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 0
Skin and subcutaneous tissue disorders
Psoriasis 0/25 (0%) 0 1/29 (3.4%) 1 3/26 (11.5%) 3 1/25 (4%) 1 0/29 (0%) 0 2/25 (8%) 2 0/30 (0%) 0 0/23 (0%) 0
Pruritus 0/25 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 3/25 (12%) 4 1/29 (3.4%) 1 0/25 (0%) 0 1/30 (3.3%) 2 0/23 (0%) 0
Acne 0/25 (0%) 0 2/29 (6.9%) 2 0/26 (0%) 0 2/25 (8%) 2 0/29 (0%) 0 0/25 (0%) 0 2/30 (6.7%) 2 0/23 (0%) 0
Vascular disorders
Hot flush 0/25 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 2/25 (8%) 2 0/29 (0%) 0 0/25 (0%) 0 0/30 (0%) 0 0/23 (0%) 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:
NCT02969018
Other Study ID Numbers:
  • B7931004
  • 2016-004049-96
First Posted:
Nov 21, 2016
Last Update Posted:
Mar 29, 2019
Last Verified:
Mar 1, 2019