Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02974868

Collaborator

(none)

142

Enrollment

Locations

Arms

28.9

Actual Duration (Months)

2.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: PF-06651600 Drug: PF-06700841 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model Description:

The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD

Actual Study Start Date :

Dec 15, 2016

Actual Primary Completion Date :

May 15, 2019

Actual Study Completion Date :

May 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 PF-06651600	Drug: PF-06651600 200 mg QD during induction and 50 mg QD during Maintenance
Experimental: Cohort 2 PF-06700841	Drug: PF-06700841 60 mg QD during induction and 30 mg QD during maintenance
Placebo Comparator: Cohort placebo placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Cohort 1

PF-06651600

Drug: PF-06651600

200 mg QD during induction and 50 mg QD during Maintenance

Experimental: Cohort 2

PF-06700841

Drug: PF-06700841

60 mg QD during induction and 30 mg QD during maintenance

Placebo Comparator: Cohort placebo

placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 [Baseline, Week24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period [Week 28 up to Week 52]
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period [COE day 1 up to end of study]
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Number of Participants With Laboratory Abnormalities During SBE Period [Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period [COE day 1 up to end of study]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.

Secondary Outcome Measures

Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants [Baseline, Week 24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.
Percentage of Participants Achieving SALT 30 at Week 24 [Baseline, Week 24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 50 Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 75 Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 90 Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 100 Across Time (Treatment Period) [Baseline, Weeks 2,4,6,8,12,16,20,24]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Number of Participants With the IGA Score Change (Treatment Period) [baseline, Week 2,4,6,8,12,16,20,24]
The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period [baseline up to Week 24]
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Number of Participants With Laboratory Abnormalities During Treatment Period [Baseline up to Week 24]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period) [Week 24 up to Week 52]
Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.
Change From Baseline in SALT Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.
Percentage of Participants Achieving SALT 30 Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 50 Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 75 Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 90 Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 100 Across Time (SBE Period) [Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
Must have moderate to severe alopecia areata:

Exclusion Criteria:

History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
Infected with hepatitis B or hepatitis C viruses.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham, Dermatology at the Whitaker Clinic	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham, The Kirklin Clinic	Birmingham	Alabama	United States	35233
3	Southern California Dermatology, Inc.	Santa Ana	California	United States	92701
4	Clinical Science Institute	Santa Monica	California	United States	90404
5	Office of F. Monte Purcelli	Santa Monica	California	United States	90404
6	Tower Saint John's Imaging	Santa Monica	California	United States	90404
7	University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit	Aurora	Colorado	United States	80045
8	University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic	Aurora	Colorado	United States	80045
9	University of Colorado Hospital, Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
10	Yale School of Medicine	New Haven	Connecticut	United States	06510
11	Investigational Drug Services	New Haven	Connecticut	United States	06511
12	Church Street Research Unit	New Haven	Connecticut	United States	06519
13	Yale Hearing and Balance Center	New Haven	Connecticut	United States	06519
14	Yale New Haven Hospital	New Haven	Connecticut	United States	06519
15	Park Avenue Dermatology Administrative Annex	Orange Park	Florida	United States	32073
16	Park Avenue Dermatology	Orange Park	Florida	United States	32073
17	Edward B. Kampsen, MD	Tampa	Florida	United States	33609
18	Olympian Clinical Research	Tampa	Florida	United States	33609
19	Rose Radiology	Tampa	Florida	United States	33609
20	Forward Clinical Trials, Inc	Tampa	Florida	United States	33624
21	MedaPhase Inc.	Newnan	Georgia	United States	30263
22	NorthShore University HealthSystem Dermatology Clinical Trials Unit	Skokie	Illinois	United States	60077
23	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256
24	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana	United States	46256
25	Tufts Medical Center	Boston	Massachusetts	United States	02111
26	Massachusetts General Hospital Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts	United States	02114
27	Weill Cornell Medicine	New York	New York	United States	10021
28	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
29	Mount Sinai Department of Otolaryngology	New York	New York	United States	10029
30	Rockefeller University Hospital	New York	New York	United States	10065
31	Investigational Drug Service	Rochester	New York	United States	14642
32	University of Rochester Audiology	Rochester	New York	United States	14642
33	University of Rochester Medical Center	Rochester	New York	United States	14642
34	University of Rochester Radiology	Rochester	New York	United States	14642
35	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma	United States	74136
36	Health Concepts	Rapid City	South Dakota	United States	57702
37	University of Utah MidValley Dermatology	Murray	Utah	United States	84107
38	University of Utah Medical Center	Salt Lake City	Utah	United States	84132
39	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
40	Hearing Life	Hurstville	New South Wales	Australia	2220
41	Dr. Glen and Partners Medical Imaging	Kogarah	New South Wales	Australia	2217
42	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales	Australia	2217
43	St. George Hearing and Balance Clinic	Kogarah	New South Wales	Australia	2217
44	The Skin Centre	Benowa	Queensland	Australia	4217
45	Veracity Clinical Research	Woolloongabba	Queensland	Australia	4102
46	Skin & Cancer Foundation Inc.	Carlton	Victoria	Australia	3053
47	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
48	Bridge Road Imag ing	Richmond	Victoria	Australia	3121
49	Richmond Audiology	Richmond	Victoria	Australia	3121
50	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
51	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X2
52	Research by ICLS	Oakville	Ontario	Canada	L6J 7W5
53	SKiN Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
54	The Centre for Dermatology	Richmond Hill	Ontario	Canada	L4B 1A5
55	York Dermatology Center	Richmond Hill	Ontario	Canada	L4C 9M7

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02974868

Other Study ID Numbers:

B7931005
2016-004048-13
ALLEGRO

First Posted:

Nov 29, 2016

Last Update Posted:

May 26, 2020

Last Verified:

May 1, 2020

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:

Keywords provided by Pfizer

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

PF-06700841

Study Results

Participant Flow

Recruitment Details	The study had a 24 week Treatment Period, a 4 week Drug Holiday, an up to 48 weeks(24 weeks + additional 24 Weeks for those received active retreatment) Single Blind Extension Period, a 4 week Drug Holiday, a 24 weeks Cross Over Open Label Extension Period.
Pre-assignment Detail	Criteria for entering SBE: complete the former period without showing Key Exclusion defined in CSR Section 9.3.2. Criteria for entering COE: non-responders (SALT change from baseline <30%) at Week 24 and continued to be non-responders at Week 52 in SBE period without showing Key Exclusion defined in CSR Section 9.3.2.

Arm/Group Title	Placebo for PF-06651600	Placebo for PF-06700841	PF-06651600	PF-06700841
Arm/Group Description	Participants received placebo tablets QD matching for PF-06651600.	Participants received placebo tablets QD matching for PF-06700841.	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Period Title: Initial 24-Week Treatment Period (TP)
STARTED	24	23	48	47
COMPLETED	20	14	45	35
NOT COMPLETED	4	9	3	12
Period Title: Initial 24-Week Treatment Period (TP)
STARTED	17	12	38	29
COMPLETED	15	11	27	23
NOT COMPLETED	2	1	11	6
Period Title: Initial 24-Week Treatment Period (TP)
STARTED	7	2	11	3
COMPLETED	5	1	8	3
NOT COMPLETED	2	1	3	0

Baseline Characteristics

Arm/Group Title	TP:Placebo	TP:PF-06651600	TP:PF-06700841	Total
Arm/Group Description	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.	Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Total of all reporting groups
Overall Participants	47	48	47	142
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.17 (14.22)	36.88 (12.62)	33.94 (11.43)	36.33 (12.84)
Age, Customized (Count of Participants)
18-44 Years	31 66%	33 68.8%	40 85.1%	104 73.2%
45-64 Years	15 31.9%	14 29.2%	6 12.8%	35 24.6%
>=65 Years	1 2.1%	1 2.1%	1 2.1%	3 2.1%
Sex: Female, Male (Count of Participants)
Female	29 61.7%	37 77.1%	32 68.1%	98 69%
Male	18 38.3%	11 22.9%	15 31.9%	44 31%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.3%	3 6.3%	5 10.6%	10 7%
Not Hispanic or Latino	45 95.7%	45 93.8%	42 89.4%	132 93%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	45 95.7%	38 79.2%	36 76.6%	119 83.8%
Black or African American	0 0%	4 8.3%	3 6.4%	7 4.9%
Asian	2 4.3%	3 6.3%	3 6.4%	8 5.6%
American Indian or Alaska Native	0 0%	0 0%	1 2.1%	1 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
other	0 0%	3 6.3%	4 8.5%	7 4.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).
Time Frame	Baseline, Week24

Outcome Measure Data

Analysis Population Description
Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data at Week 24

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Least Squares Mean (90% Confidence Interval) [units on a scale]	32.54	50.59	1.41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-06651600, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<.0001
	Comments	Hochberg P-value (one-sided)
	Method	Mixed Model Repeated Measure (MMRM)
	Comments	MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.

Method of Estimation	Estimation Parameter	Mean of Difference from Placebo
	Estimated Value	31.14
	Confidence Interval	(2-Sided) 95% 18.78 to 43.50
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-06700841, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<.0001
	Comments	Hochberg P-value (one-sided)
	Method	Mixed Model Repeated Measure (MMRM)
	Comments	MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.

Method of Estimation	Estimation Parameter	Mean of Difference from Placebo
	Estimated Value	49.18
	Confidence Interval	(2-Sided) 95% 36.62 to 61.74
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.35
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
Number of Participants Analyzed: AT/AU participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. Number Analyzed: Number of participants with observed data at Week 24.

Arm/Group Title	PF-06651600-AT/AU	PF-06700841-AT/AU	Placebo-AT/AU
Arm/Group Description	AT/AU Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	AT/AU Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	AT/AU Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
Measure Participants	20	22	20
Least Squares Mean (90% Confidence Interval) [units on a scale]	27.59	48.42	1.81

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-06651600, Placebo
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0094
	Comments
	Method	Mixed Model Repeated Measure (MMRM)
	Comments	MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.

Method of Estimation	Estimation Parameter	Mean of Difference from Placebo
	Estimated Value	25.78
	Confidence Interval	(2-Sided) 90% 7.98 to 43.58
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.64
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-06700841, Placebo
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Mixed Model Repeated Measure
	Comments	MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.

Method of Estimation	Estimation Parameter	Mean of Difference from Placebo
	Estimated Value	46.61
	Confidence Interval	(2-Sided) 90% 29.02 to 64.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.51
	Estimation Comments

3. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.
Time Frame	Week 28 up to Week 52

Outcome Measure Data

Analysis Population Description
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.

Arm/Group Title	Active Non-responders on PF-06651600	Placebo Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06700841	Non-Retreated PF-06651600 Responders in the Withdrawal Segment	Retreated PF-06651600 Responders in the Withdrawal Segment	Non-Retreated PF-06700841 Responders in the Withdrawal Segment	Retreated PF-06700841 Responders in the Withdrawal Segment	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	17	5	12	8	14	9	14	14	15
TEAE (All Causalities)	8 17%	12 25%	4 8.5%	10 7%	4 NaN	3 NaN	6 NaN	9 NaN	11 NaN	9 NaN
TEAE (Treatment Related)	5 10.6%	1 2.1%	0 0%	1 0.7%	0 NaN	1 NaN	0 NaN	3 NaN	2 NaN	2 NaN

4. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Time Frame	COE day 1 up to end of study

Outcome Measure Data

Analysis Population Description
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.

Arm/Group Title	COE-PF-06651600	COE-PF-06700841
Arm/Group Description	Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period	Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
Measure Participants	5	18
TEAE (All Causalities)	4 8.5%	9 18.8%
TEAE (Treatment Related)	2 4.3%	3 6.3%

5. Primary Outcome

Title	Number of Participants With Laboratory Abnormalities During SBE Period
Description	Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame	Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)

Outcome Measure Data

Analysis Population Description
The safety analysis set (SAS) was used. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder skipped the withdrawal segment and entered the retreatment segment.

Arm/Group Title	Active Non-responders on PF-06651600	Placebo Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06700841	Non-Retreated PF-06651600 Responders in the Withdrawal Segment	Retreated PF-06651600 Responders in the Withdrawal Segment	Non-Retreated PF-06700841 Responders in the Withdrawal Segment	Retreated PF-06700841 Responders in the Withdrawal Segment	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	17	5	12	8	14	9	14	14	15
With abnormalities without regard to baseline	13 27.7%	11 22.9%	4 8.5%	11 7.7%	6 NaN	9 NaN	7 NaN	10 NaN	11 NaN	14 NaN
Meeting Retest Criteria	3 6.4%	5 10.4%	2 4.3%	7 4.9%	2 NaN	0 NaN	3 NaN	2 NaN	4 NaN	4 NaN
Meeting Discontinuation Criteria	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN

6. Primary Outcome

Title	Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
Description	Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame	COE day 1 up to end of study

Outcome Measure Data

Analysis Population Description
All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in COE period.

Arm/Group Title	COE-PF-06651600	COE-PF-06700841
Arm/Group Description	Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period	Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
Measure Participants	5	18
With abnormalities without regard to baseline	5 10.6%	11 22.9%
Meeting Retest Criteria	1 2.1%	6 12.5%
Meeting Discontinuation Criteria	0 0%	0 0%

7. Secondary Outcome

Title	Percentage of Participants Achieving SALT 30 at Week 24
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used and have observed data at Week 24. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Number (90% Confidence Interval) [percentage of participants]	50.0 106.4%	63.8 132.9%	2.1 4.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-06651600, Placebo
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chan and Zhang method
	Comments

Method of Estimation	Estimation Parameter	Difference in Percentage from Placebo
	Estimated Value	47.9
	Confidence Interval	(2-Sided) 90% 34.2 to 60.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-06700841, Placebo
	Comments
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chan and Zhang method
	Comments

Method of Estimation	Estimation Parameter	Difference in Percentage from Placebo
	Estimated Value	61.7
	Confidence Interval	(2-Sided) 90% 48.2 to 73.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	-0.74	-0.93	1.18
Week 4	2.93	7.70	0.85
Week 6	12.44	19.37	1.32
Week 8	18.49	29.30	1.77
Week 12	24.49	36.57	1.62
Week 16	27.59	41.16	1.61
Week 20	29.32	45.55	1.62
Week 24	31.14	49.18	1.41

9. Secondary Outcome

Title	Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	-0.76	-1.13	1.26
Week 4	3.99	9.70	0.53
Week 6	15.88	22.88	1.02
Week 8	23.22	34.78	1.31
Week 12	30.99	44.17	0.99
Week 16	35.14	49.99	0.86
Week 20	37.31	55.46	0.91
Week 24	39.67	59.71	0.43

10. Secondary Outcome

Title	Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	-2.1 -4.5%	-2.1 -4.4%	2.1 4.5%
Week 4	6.2 13.2%	12.8 26.7%	2.1 4.5%
Week 6	18.7 39.8%	27.7 57.7%	2.1 4.5%
Week 8	25.0 53.2%	38.3 79.8%	2.1 4.5%
Week 12	39.5 84%	48.9 101.9%	2.1 4.5%
Week 16	45.8 97.4%	55.3 115.2%	2.1 4.5%
Week 20	47.9 101.9%	59.6 124.2%	2.1 4.5%
Week 24	47.9 101.9%	61.7 128.5%	2.1 4.5%

11. Secondary Outcome

Title	Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	0.0 0%	0.0 0%	0 0%
Week 4	0.0 0%	10.6 22.1%	0 0%
Week 6	10.4 22.1%	17.0 35.4%	2.1 4.5%
Week 8	18.7 39.8%	29.8 62.1%	2.1 4.5%
Week 12	27.0 57.4%	36.2 75.4%	2.1 4.5%
Week 16	33.3 70.9%	40.4 84.2%	2.1 4.5%
Week 20	33.3 70.9%	46.8 97.5%	2.1 4.5%
Week 24	37.5 79.8%	51.1 106.5%	2.1 4.5%

12. Secondary Outcome

Title	Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	0.0 0%	0.0 0%	0 0%
Week 4	0.0 0%	0.0 0%	0 0%
Week 6	8.3 17.7%	10.6 22.1%	0 0%
Week 8	12.5 26.6%	23.4 48.8%	2.1 4.5%
Week 12	16.6 35.3%	27.7 57.7%	2.1 4.5%
Week 16	20.8 44.3%	31.9 66.5%	2.1 4.5%
Week 20	25.0 53.2%	38.3 79.8%	2.1 4.5%
Week 24	27.0 57.4%	40.4 84.2%	2.1 4.5%

13. Secondary Outcome

Title	Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	0.0 0%	0.0 0%	0 0%
Week 4	0.0 0%	0.0 0%	0 0%
Week 6	0.0 0%	6.4 13.3%	0 0%
Week 8	4.2 8.9%	12.8 26.7%	0 0%
Week 12	10.4 22.1%	25.5 53.1%	0 0%
Week 16	16.7 35.5%	27.7 57.7%	0 0%
Week 20	18.7 39.8%	29.8 62.1%	2.1 4.5%
Week 24	25.0 53.2%	34.0 70.8%	0 0%

14. Secondary Outcome

Title	Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Baseline, Weeks 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
Week 2	0.0 0%	0.0 0%	0 0%
Week 4	0.0 0%	0.0 0%	0 0%
Week 6	0.0 0%	0.0 0%	0 0%
Week 8	0.0 0%	2.1 4.4%	0 0%
Week 12	2.1 4.5%	6.4 13.3%	0 0%
Week 16	2.1 4.5%	8.5 17.7%	0 0%
Week 20	4.2 8.9%	12.8 26.7%	0 0%
Week 24	12.5 26.6%	12.8 26.7%	0 0%

15. Secondary Outcome

Title	Number of Participants With the IGA Score Change (Treatment Period)
Description	The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).
Time Frame	baseline, Week 2,4,6,8,12,16,20,24

Outcome Measure Data

Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
0 (NO CHANGE OR FURTHER LOSS)	48 102.1%	47 97.9%	47 100%
1 (1-24% REGROWTH)	0 0%	0 0%	0 0%
2 (25-49% REGROWTH)	0 0%	0 0%	0 0%
3 (50-74% REGROWTH)	0 0%	0 0%	0 0%
4 (75-99% REGROWTH)	0 0%	0 0%	0 0%
5 (100% REGROWTH)	0 0%	0 0%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	40 85.1%	43 89.6%	40 85.1%
1 (1-24% REGROWTH)	8 17%	4 8.3%	5 10.6%
2 (25-49% REGROWTH)	0 0%	0 0%	1 2.1%
3 (50-74% REGROWTH)	0 0%	0 0%	0 0%
4 (75-99% REGROWTH)	0 0%	0 0%	0 0%
5 (100% REGROWTH)	0 0%	0 0%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	29 61.7%	21 43.8%	36 76.6%
1 (1-24% REGROWTH)	15 31.9%	19 39.6%	6 12.8%
2 (25-49% REGROWTH)	4 8.5%	2 4.2%	1 2.1%
3 (50-74% REGROWTH)	0 0%	5 10.4%	0 0%
4 (75-99% REGROWTH)	0 0%	0 0%	0 0%
5 (100% REGROWTH)	0 0%	0 0%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	16 34%	10 20.8%	35 74.5%
1 (1-24% REGROWTH)	18 38.3%	17 35.4%	6 12.8%
2 (25-49% REGROWTH)	7 14.9%	9 18.8%	1 2.1%
3 (50-74% REGROWTH)	2 4.3%	4 8.3%	1 2.1%
4 (75-99% REGROWTH)	4 8.5%	5 10.4%	0 0%
5 (100% REGROWTH)	0 0%	0 0%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	13 27.7%	7 14.6%	33 70.2%
1 (1-24% REGROWTH)	17 36.2%	17 35.4%	9 19.1%
2 (25-49% REGROWTH)	7 14.9%	5 10.4%	1 2.1%
3 (50-74% REGROWTH)	3 6.4%	3 6.3%	0 0%
4 (75-99% REGROWTH)	7 14.9%	11 22.9%	1 2.1%
5 (100% REGROWTH)	0 0%	1 2.1%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	13 27.7%	6 12.5%	33 70.2%
1 (1-24% REGROWTH)	11 23.4%	11 22.9%	10 21.3%
2 (25-49% REGROWTH)	9 19.1%	9 18.8%	1 2.1%
3 (50-74% REGROWTH)	5 10.6%	4 8.3%	0 0%
4 (75-99% REGROWTH)	8 17%	10 20.8%	1 2.1%
5 (100% REGROWTH)	1 2.1%	4 8.3%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	14 29.8%	5 10.4%	31 66%
1 (1-24% REGROWTH)	7 14.9%	7 14.6%	9 19.1%
2 (25-49% REGROWTH)	7 14.9%	9 18.8%	1 2.1%
3 (50-74% REGROWTH)	6 12.8%	4 8.3%	0 0%
4 (75-99% REGROWTH)	10 21.3%	11 22.9%	1 2.1%
5 (100% REGROWTH)	1 2.1%	5 10.4%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	14 29.8%	4 8.3%	29 61.7%
1 (1-24% REGROWTH)	6 12.8%	6 12.5%	9 19.1%
2 (25-49% REGROWTH)	8 17%	7 14.6%	1 2.1%
3 (50-74% REGROWTH)	4 8.5%	4 8.3%	0 0%
4 (75-99% REGROWTH)	10 21.3%	11 22.9%	1 2.1%
5 (100% REGROWTH)	3 6.4%	8 16.7%	0 0%
0 (NO CHANGE OR FURTHER LOSS)	13 27.7%	4 8.3%	27 57.4%
1 (1-24% REGROWTH)	5 10.6%	6 12.5%	6 12.8%
2 (25-49% REGROWTH)	7 14.9%	5 10.4%	1 2.1%
3 (50-74% REGROWTH)	5 10.6%	5 10.4%	0 0%
4 (75-99% REGROWTH)	8 17%	13 27.1%	1 2.1%
5 (100% REGROWTH)	6 12.8%	7 14.6%	0 0%

16. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period
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. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Time Frame	baseline up to Week 24

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) in Treatment Period.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	47
TEAE (All Causalities)	32 68.1%	36 75%	35 74.5%
TEAE (Treatment Related)	13 27.7%	20 41.7%	14 29.8%

17. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities During Treatment Period
Description	Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description
All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in treatment period.

Arm/Group Title	PF-06651600	PF-06700841	Placebo
Arm/Group Description	Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Measure Participants	48	47	46
With abnormalities without regard to baseline	35 74.5%	36 75%	32 68.1%
Meeting Safety Criteria	12 25.5%	29 60.4%	5 10.6%
Meeting Retest Criteria	5 10.6%	18 37.5%	9 19.1%
Meeting Discontinuation Criteria	0 0%	3 6.3%	0 0%

18. Secondary Outcome

Title	Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period)
Description	Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.
Time Frame	Week 24 up to Week 52

Outcome Measure Data

Analysis Population Description
All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).

Arm/Group Title	PF-06651600 Responders	PF-06700841 Responders
Arm/Group Description	Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)	Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)
Measure Participants	22	24
Q1 time to retreatment (25th percentile of time)	10.1	11.0
Median time to retreatment	16.1	24.1
Q3 time to retreatment (75th percentile of time)	21.1	NA

19. Secondary Outcome

Title	Change From Baseline in SALT Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data. 6 groups of participants were each compared with initial 24-week treatment period placebo.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	1.76	0.09	2.99	-0.31	25.04	19.83
Week 32/ AT Week 4	1.85	2.22	3.37	3.71	27.63	15.66
Week 34/ AT Week 6	1.80	3.16	10.16	24.67	33.78	20.09
Week 36/ AT Week 8	2.16	3.01	8.93	42.32	38.80	27.35
Week 40/ AT Week 12	3.35	3.19	18.30	50.27	43.70	39.28
Week 44/ AT Week 16	3.41	3.12	25.71	54.69	48.93	50.58
Week 48/ AT Week 20	4.70	2.97	25.28	62.45	53.74	53.79
Week 52/ AT Week 24	7.06	3.01	28.88	58.53	55.94	58.37

20. Secondary Outcome

Title	Percentage of Participants Achieving SALT 30 Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	4.1 8.7%	-2.1 -4.4%	3.8 8.1%	-2.1 -1.5%	47.9 NaN	31.2 NaN
Week 32/ AT Week 4	4.1 8.7%	-2.1 -4.4%	9.6 20.4%	14.5 10.2%	62.2 NaN	11.2 NaN
Week 34/ AT Week 6	4.1 8.7%	-2.1 -4.4%	21.4 45.5%	31.2 22%	69.3 NaN	31.2 NaN
Week 36/ AT Week 8	4.1 8.7%	-2.1 -4.4%	21.4 45.5%	56.2 39.6%	69.3 NaN	44.5 NaN
Week 40/ AT Week 12	10.4 22.1%	-2.1 -4.4%	27.3 58.1%	81.2 57.2%	62.2 NaN	51.2 NaN
Week 44/ AT Week 16	10.4 22.1%	-2.1 -4.4%	33.2 70.6%	64.5 45.4%	62.2 NaN	51.2 NaN
Week 48/ AT Week 20	10.4 22.1%	-2.1 -4.4%	39.0 83%	64.5 45.4%	69.3 NaN	51.2 NaN
Week 52/ AT Week 24	10.4 22.1%	-2.1 -4.4%	27.3 58.1%	64.5 45.4%	55.0 NaN	51.2 NaN

21. Secondary Outcome

Title	Percentage of Participants Achieving SALT 50 Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	0.0 0%	0.0 0%	0.0 0%	0.0 0%	14.3 NaN	20.0 NaN
Week 32/ AT Week 4	0.0 0%	0.0 0%	0.0 0%	0.0 0%	21.4 NaN	6.7 NaN
Week 34/ AT Week 6	-2.1 -4.5%	-2.1 -4.4%	9.6 20.4%	31.2 22%	26.4 NaN	11.2 NaN
Week 36/ AT Week 8	-2.1 -4.5%	-2.1 -4.4%	3.8 8.1%	56.2 39.6%	33.6 NaN	24.5 NaN
Week 40/ AT Week 12	-2.1 -4.5%	-2.1 -4.4%	15.5 33%	56.2 39.6%	47.9 NaN	44.5 NaN
Week 44/ AT Week 16	-2.1 -4.5%	-2.1 -4.4%	21.4 45.5%	64.5 45.4%	47.9 NaN	44.5 NaN
Week 48/ AT Week 20	4.1 8.7%	-2.1 -4.4%	27.3 58.1%	64.5 45.4%	47.9 NaN	37.9 NaN
Week 52/ AT Week 24	4.1 8.7%	-2.1 -4.4%	27.3 58.1%	64.5 45.4%	47.9 NaN	44.5 NaN

22. Secondary Outcome

Title	Percentage of Participants Achieving SALT 75 Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 32/ AT Week 4	0.0 0%	0.0 0%	0.0 0%	0.0 0%	7.1 NaN	0.0 NaN
Week 34/ AT Week 6	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	14.3 NaN	6.7 NaN
Week 36/ AT Week 8	-2.1 -4.5%	-2.1 -4.4%	-2.1 -4.5%	22.9 16.1%	26.4 NaN	17.9 NaN
Week 40/ AT Week 12	-2.1 -4.5%	-2.1 -4.4%	3.8 8.1%	39.5 27.8%	26.4 NaN	31.2 NaN
Week 44/ AT Week 16	-2.1 -4.5%	-2.1 -4.4%	15.5 33%	56.2 39.6%	26.4 NaN	37.9 NaN
Week 48/ AT Week 20	-2.1 -4.5%	-2.1 -4.4%	15.5 33%	64.5 45.4%	28.6 NaN	37.9 NaN
Week 52/ AT Week 24	4.1 8.7%	-2.1 -4.4%	27.3 58.1%	64.5 45.4%	33.6 NaN	37.9 NaN

23. Secondary Outcome

Title	Percentage of Participants Achieving SALT 90 Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 32/ AT Week 4	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 34/ AT Week 6	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 36/ AT Week 8	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	7.1 NaN	6.7 NaN
Week 40/ AT Week 12	0.0 0%	0.0 0%	0.0 0%	25.0 17.6%	14.3 NaN	13.3 NaN
Week 44/ AT Week 16	0.0 0%	0.0 0%	0.0 0%	33.3 23.5%	21.4 NaN	20.0 NaN
Week 48/ AT Week 20	-2.1 -4.5%	-2.1 -4.4%	3.8 8.1%	47.9 33.7%	26.4 NaN	24.5 NaN
Week 52/ AT Week 24	0.0 0%	0.0 0%	17.6 37.4%	50.0 35.2%	28.6 NaN	40.0 NaN

24. Secondary Outcome

Title	Percentage of Participants Achieving SALT 100 Across Time (SBE Period)
Description	SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame	Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Outcome Measure Data

Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Active Non-responders on PF-06651600	Active Non-responders on PF-06700841	Placebo Non-responders on PF-06651600	Placebo Non-responders on PF-06700841	Retreated PF-06651600 Responders in the Retreatment Segment	Retreated Responders on PF-06700841 in the Retreatment Segment
Arm/Group Description	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period	Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period	Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600	Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Measure Participants	16	5	17	12	14	15
Week 30/ AT Week 2	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 32/ AT Week 4	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 34/ AT Week 6	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 36/ AT Week 8	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN
Week 40/ AT Week 12	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	7.1 NaN	0.0 NaN
Week 44/ AT Week 16	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	7.1 NaN	13.3 NaN
Week 48/ AT Week 20	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	7.1 NaN	20.0 NaN
Week 52/ AT Week 24	0.0 0%	0.0 0%	0.0 0%	8.3 5.8%	14.3 NaN	20.0 NaN

Adverse Events

	Treatment Period-Placebo		Treatment Period-PF-06651600		Treatment Period-PF-06700841		Single Blind Extension-Active Non-responders on PF-06651600		Single Blind Extension-Placebo Non-responders on PF-06651600		Single Blind Extension-Active Non-responders on PF-06700841		Single Blind Extension-Placebo Non-responders on PF-06700841		SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)		SBE-Retreated PF-06700841 Responders in the Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Retreatment Segment		SBE-Retreated Responders on PF-06700841 in Retreatment Segment		Cross Over Extension-PF-06651600		Cross Over Extension-PF-06700841
Time Frame	From first dose of study treatment up to 113 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. Participants were counted only once per treatment per event.

Arm/Group Title	Treatment Period-Placebo		Treatment Period-PF-06651600		Treatment Period-PF-06700841		Single Blind Extension-Active Non-responders on PF-06651600		Single Blind Extension-Placebo Non-responders on PF-06651600		Single Blind Extension-Active Non-responders on PF-06700841		Single Blind Extension-Placebo Non-responders on PF-06700841		SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)		SBE-Retreated PF-06700841 Responders in the Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Retreatment Segment		SBE-Retreated Responders on PF-06700841 in Retreatment Segment		Cross Over Extension-PF-06651600		Cross Over Extension-PF-06700841
Arm/Group Description	Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841		Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.		Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.		Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period		Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period		Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period		Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period		Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period		Participants initially treated with PF-06651600 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm described AEs for retreated responders within withdrawal Segment.		Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period		Participants initially treated with PF06700841 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841.This arm described AEs for retreated responders within Withdrawal Segment		Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600		Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841		Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period		Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
All Cause Mortality
	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	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	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Serious Adverse Events
	Treatment Period-Placebo		Treatment Period-PF-06651600		Treatment Period-PF-06700841		Single Blind Extension-Active Non-responders on PF-06651600		Single Blind Extension-Placebo Non-responders on PF-06651600		Single Blind Extension-Active Non-responders on PF-06700841		Single Blind Extension-Placebo Non-responders on PF-06700841		SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)		SBE-Retreated PF-06700841 Responders in the Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Retreatment Segment		SBE-Retreated Responders on PF-06700841 in Retreatment Segment		Cross Over Extension-PF-06651600		Cross Over Extension-PF-06700841
	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	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	0/47 (0%)		0/48 (0%)		2/47 (4.3%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		1/18 (5.6%)
Infections and infestations
Gastroenteritis salmonella	0/47 (0%)		0/48 (0%)		1/47 (2.1%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Injury, poisoning and procedural complications
Lower limb fracture	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	0/47 (0%)		0/48 (0%)		2/47 (4.3%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Period-Placebo		Treatment Period-PF-06651600		Treatment Period-PF-06700841		Single Blind Extension-Active Non-responders on PF-06651600		Single Blind Extension-Placebo Non-responders on PF-06651600		Single Blind Extension-Active Non-responders on PF-06700841		Single Blind Extension-Placebo Non-responders on PF-06700841		SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Withdrawal Segment		SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)		SBE-Retreated PF-06700841 Responders in the Withdrawal Segment		SBE-Retreated PF-06651600 Responders in Retreatment Segment		SBE-Retreated Responders on PF-06700841 in Retreatment Segment		Cross Over Extension-PF-06651600		Cross Over Extension-PF-06700841
	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	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	26/47 (55.3%)		23/48 (47.9%)		28/47 (59.6%)		8/16 (50%)		12/17 (70.6%)		4/5 (80%)		10/12 (83.3%)		4/8 (50%)		3/14 (21.4%)		6/9 (66.7%)		9/14 (64.3%)		11/14 (78.6%)		8/15 (53.3%)		4/5 (80%)		8/18 (44.4%)
Blood and lymphatic system disorders
Lymphadenopathy	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Cardiac disorders
Palpitations	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		1/8 (12.5%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Ventricular extrasystoles	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Ear and labyrinth disorders
Tinnitus	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Eye disorders
Eyelids pruritus	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Gastrointestinal disorders
Abdominal discomfort	4/47 (8.5%)		0/48 (0%)		1/47 (2.1%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Abdominal pain	0/47 (0%)		0/48 (0%)		3/47 (6.4%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Abdominal pain upper	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Constipation	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Diarrhoea	3/47 (6.4%)		4/48 (8.3%)		1/47 (2.1%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Dyspepsia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Lip oedema	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Nausea	5/47 (10.6%)		3/48 (6.3%)		3/47 (6.4%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Toothache	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Vomiting	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Aphthous ulcer	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
General disorders
Fatigue	3/47 (6.4%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		2/9 (22.2%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Inflammation	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Pyrexia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Influenza like illness	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Immune system disorders
Seasonal allergy	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Infections and infestations
Acute sinusitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Bronchitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		2/16 (12.5%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Conjunctivitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Folliculitis	1/47 (2.1%)		3/48 (6.3%)		1/47 (2.1%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Gastroenteritis viral	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Herpes simplex	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Influenza	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		1/12 (8.3%)		0/8 (0%)		1/14 (7.1%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Nasopharyngitis	6/47 (12.8%)		6/48 (12.5%)		4/47 (8.5%)		0/16 (0%)		2/17 (11.8%)		0/5 (0%)		2/12 (16.7%)		0/8 (0%)		1/14 (7.1%)		1/9 (11.1%)		0/14 (0%)		3/14 (21.4%)		1/15 (6.7%)		1/5 (20%)		0/18 (0%)
Oral herpes	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		1/14 (7.1%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Otitis externa	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Pharyngitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		1/8 (12.5%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Pharyngitis streptococcal	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Sinusitis	2/47 (4.3%)		0/48 (0%)		3/47 (6.4%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		1/12 (8.3%)		0/8 (0%)		1/14 (7.1%)		1/9 (11.1%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Sinusitis bacterial	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Soft tissue infection	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Tinea versicolour	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Tonsillitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Upper respiratory tract infection	5/47 (10.6%)		4/48 (8.3%)		11/47 (23.4%)		2/16 (12.5%)		0/17 (0%)		1/5 (20%)		1/12 (8.3%)		1/8 (12.5%)		0/14 (0%)		1/9 (11.1%)		2/14 (14.3%)		2/14 (14.3%)		1/15 (6.7%)		1/5 (20%)		3/18 (16.7%)
Urinary tract infection	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Viral infection	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Viral upper respiratory tract infection	0/47 (0%)		2/48 (4.2%)		3/47 (6.4%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		1/18 (5.6%)
Hordeolum	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Rhinitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Arthritis viral	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Bartholin's abscess	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Ear infection	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Laryngitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Orchitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Injury, poisoning and procedural complications
Chest injury	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Head injury	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Muscle strain	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Thermal burn	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Wound	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		1/8 (12.5%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Contusion	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Skin laceration	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Investigations
Blood creatine phosphokinase increased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Blood creatinine increased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Glomerular filtration rate decreased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Liver function test abnormal	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Liver function test increased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		2/14 (14.3%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Neutrophil count decreased	1/47 (2.1%)		0/48 (0%)		3/47 (6.4%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Alanine aminotransferase increased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Blood potassium decreased	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		1/14 (7.1%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Metabolism and nutrition disorders
Hyperkalaemia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Hyperlipidaemia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Musculoskeletal pain	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		1/8 (12.5%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Myalgia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		1/14 (7.1%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Pain in extremity	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		2/17 (11.8%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Rhabdomyolysis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Torticollis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Nervous system disorders
Dizziness	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		2/14 (14.3%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Dysgeusia	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Headache	5/47 (10.6%)		6/48 (12.5%)		4/47 (8.5%)		2/16 (12.5%)		2/17 (11.8%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		1/14 (7.1%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		2/15 (13.3%)		0/5 (0%)		1/18 (5.6%)
Migraine	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Nerve compression	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Taste disorder	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Depressed level of consciousness	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Psychiatric disorders
Aggression	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/5 (0%)		0/18 (0%)
Anxiety	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Renal and urinary disorders
Haematuria	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
IgA nephropathy	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Nephrolithiasis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Proteinuria	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		1/17 (5.9%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Respiratory disorder	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Wheezing	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Oropharyngeal pain	0/47 (0%)		0/48 (0%)		3/47 (6.4%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Nasal congestion	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Skin and subcutaneous tissue disorders
Acne	2/47 (4.3%)		5/48 (10.4%)		5/47 (10.6%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Dermatitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		2/12 (16.7%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Dermatitis atopic	0/47 (0%)		3/48 (6.3%)		1/47 (2.1%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		1/9 (11.1%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Dermatitis contact	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Keratosis pilaris	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Madarosis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Papulopustular rosacea	0/47 (0%)		0/48 (0%)		0/47 (0%)		1/16 (6.3%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Pruritus	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		1/5 (20%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		1/5 (20%)		0/18 (0%)
Pseudofolliculitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		1/12 (8.3%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Seborrhoeic dermatitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Urticaria	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Urticaria papular	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		1/17 (5.9%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		0/18 (0%)
Hidradenitis	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)
Erythema	0/47 (0%)		0/48 (0%)		0/47 (0%)		0/16 (0%)		0/17 (0%)		0/5 (0%)		0/12 (0%)		0/8 (0%)		0/14 (0%)		0/9 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/5 (0%)		1/18 (5.6%)

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:

NCT02974868

Other Study ID Numbers:

B7931005
2016-004048-13
ALLEGRO

First Posted:

Nov 29, 2016

Last Update Posted:

May 26, 2020

Last Verified:

May 1, 2020

Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact