Study To Evaluate The Efficacy And Safety Profile Of PF-0... | NCT02974868 | Trialant
NCT02974868
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 26, 2020Actual
Enrollment
142Actual
Phase
Phase 2
Conditions
Alopecia Areata
Interventions
PF-06651600
PF-06700841
Placebo
Countries
United States
Australia
Canada
Protocol Section
Identification Module
NCT ID
NCT02974868
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7931005
Secondary IDs
ID
Type
Description
Link
2016-004048-13
EudraCT Number
ALLEGRO
Other Identifier
Alias Study Number
Brief Title
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
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
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 15, 2016Actual
Primary Completion Date
May 15, 2019Actual
Completion Date
May 15, 2019Actual
First Submitted Date
Nov 23, 2016
First Submission Date that Met QC Criteria
Nov 23, 2016
First Posted Date
Nov 29, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 6, 2020
Results First Submitted that Met QC Criteria
May 6, 2020
Results First Posted Date
May 26, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 6, 2020
Last Update Posted Date
May 26, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia Areata
Keywords
Phase 2
randomized
double-blind
placebo
alopecia areata
safety
efficacy
JAK
janus kinase
moderate
severe
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
142Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
PF-06651600
Drug: PF-06651600
Cohort 2
Experimental
PF-06700841
Drug: PF-06700841
Cohort placebo
Placebo Comparator
placebo
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06651600
Drug
200 mg QD during induction and 50 mg QD during Maintenance
Cohort 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
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).
Baseline, Week24
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
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.
Week 28 up to Week 52
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
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.
COE day 1 up to end of study
Number of Participants With Laboratory Abnormalities During SBE Period
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 Outcomes
Measure
Description
Time Frame
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Senna M, Soung J, Figueras I, King B, Kinoshita-Ise M, Hanna S, Wu W, Wajsbrot D, Woodworth D, Wolk R, Chaudhry A, Lejeune A, Tran H. Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies. Am J Clin Dermatol. 2026 Mar 31. doi: 10.1007/s40257-026-01029-y. Online ahead of print.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo for PF-06651600
Participants received placebo tablets QD matching for PF-06651600.
FG001
Placebo for PF-06700841
Participants received placebo tablets QD matching for PF-06700841.
Periods
Title
Milestones
Reasons Not Completed
Initial 24-Week Treatment Period (TP)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 6, 2018
May 6, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Not provided
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.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
PF-06700841
Drug
60 mg QD during induction and 30 mg QD during maintenance
Cohort 2
Placebo
Drug
Placebo
Cohort placebo
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)
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
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.
COE day 1 up to end of study
Baseline, Week 24
Percentage of Participants Achieving SALT 30 at 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.
Baseline, Week 24
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)
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.
Baseline, Weeks 2,4,6,8,12,16,20,24
Number of Participants With the IGA Score Change (Treatment Period)
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).
baseline, Week 2,4,6,8,12,16,20,24
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period
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.
baseline up to Week 24
Number of Participants With Laboratory Abnormalities During Treatment Period
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.
Baseline up to Week 24
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)
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.
Week 24 up to Week 52
Change From Baseline in SALT Across Time (SBE Period)
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.
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)
Percentage of Participants Achieving SALT 30 Across Time (SBE Period)
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.
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)
Percentage of Participants Achieving SALT 50 Across Time (SBE Period)
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.
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)
Percentage of Participants Achieving SALT 75 Across Time (SBE Period)
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.
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)
Percentage of Participants Achieving SALT 90 Across Time (SBE Period)
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.
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)
Percentage of Participants Achieving SALT 100 Across Time (SBE Period)
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.
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)
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham
Alabama
35233
United States
Southern California Dermatology, Inc.
Santa Ana
California
92701
United States
Clinical Science Institute
Santa Monica
California
90404
United States
Office of F. Monte Purcelli
Santa Monica
California
90404
United States
Tower Saint John's Imaging
Santa Monica
California
90404
United States
University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit
Aurora
Colorado
80045
United States
University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic
Aurora
Colorado
80045
United States
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora
Colorado
80045
United States
Yale School of Medicine
New Haven
Connecticut
06510
United States
Investigational Drug Services
New Haven
Connecticut
06511
United States
Church Street Research Unit
New Haven
Connecticut
06519
United States
Yale Hearing and Balance Center
New Haven
Connecticut
06519
United States
Yale New Haven Hospital
New Haven
Connecticut
06519
United States
Park Avenue Dermatology Administrative Annex
Orange Park
Florida
32073
United States
Park Avenue Dermatology
Orange Park
Florida
32073
United States
Edward B. Kampsen, MD
Tampa
Florida
33609
United States
Olympian Clinical Research
Tampa
Florida
33609
United States
Rose Radiology
Tampa
Florida
33609
United States
Forward Clinical Trials, Inc
Tampa
Florida
33624
United States
MedaPhase Inc.
Newnan
Georgia
30263
United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie
Illinois
60077
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46256
United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis
Indiana
46256
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
Massachusetts General Hospital Clinical Unit for Research Trials in Skin (CURTIS)
Boston
Massachusetts
02114
United States
Weill Cornell Medicine
New York
New York
10021
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
Mount Sinai Department of Otolaryngology
New York
New York
10029
United States
Rockefeller University Hospital
New York
New York
10065
United States
Investigational Drug Service
Rochester
New York
14642
United States
University of Rochester Audiology
Rochester
New York
14642
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
University of Rochester Radiology
Rochester
New York
14642
United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa
Oklahoma
74136
United States
Health Concepts
Rapid City
South Dakota
57702
United States
University of Utah MidValley Dermatology
Murray
Utah
84107
United States
University of Utah Medical Center
Salt Lake City
Utah
84132
United States
Virginia Clinical Research, Inc.
Norfolk
Virginia
23502
United States
Hearing Life
Hurstville
New South Wales
2220
Australia
Dr. Glen and Partners Medical Imaging
Kogarah
New South Wales
2217
Australia
St George Dermatology and Skin Cancer Centre
Kogarah
New South Wales
2217
Australia
St. George Hearing and Balance Clinic
Kogarah
New South Wales
2217
Australia
The Skin Centre
Benowa
Queensland
4217
Australia
Veracity Clinical Research
Woolloongabba
Queensland
4102
Australia
Skin & Cancer Foundation Inc.
Carlton
Victoria
3053
Australia
Sinclair Dermatology
East Melbourne
Victoria
3002
Australia
Bridge Road Imag ing
Richmond
Victoria
3121
Australia
Richmond Audiology
Richmond
Victoria
3121
Australia
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
Lynderm Research Inc.
Markham
Ontario
L3P 1X2
Canada
Research by ICLS
Oakville
Ontario
L6J 7W5
Canada
SKiN Centre for Dermatology
Peterborough
Ontario
K9J 5K2
Canada
The Centre for Dermatology
Richmond Hill
Ontario
L4B 1A5
Canada
York Dermatology Center
Richmond Hill
Ontario
L4C 9M7
Canada
Derived
Xi L, Peeva E, Yamaguchi Y, Ye Z, Lejeune A, Hyde C, Guttman-Yassky E. Multiomics Analysis of the Response to Ritlecitinib in Alopecia Areata Subtypes and Correlation With Efficacy. Allergy. 2025 Aug;80(8):2348-2360. doi: 10.1111/all.16659. Epub 2025 Jul 14.
King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.
Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
Peeva E, Guttman-Yassky E, Banerjee A, Sinclair R, Cox LA, Zhu L, Zhu H, Vincent M, King B. Maintenance, withdrawal, and re-treatment with ritlecitinib and brepocitinib in patients with alopecia areata in a single-blind extension of a phase 2a randomized clinical trial. J Am Acad Dermatol. 2022 Aug;87(2):390-393. doi: 10.1016/j.jaad.2021.12.008. Epub 2021 Dec 13. No abstract available.
Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E. Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers. J Allergy Clin Immunol. 2022 Apr;149(4):1318-1328. doi: 10.1016/j.jaci.2021.10.036. Epub 2021 Dec 1.
Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.
FG002
PF-06651600
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.
FG003
PF-06700841
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.
FG00024 subjects
FG00123 subjects
FG00248 subjects
FG00347 subjects
COMPLETED
FG00020 subjects
FG00114 subjects
FG00245 subjects
FG00335 subjects
NOT COMPLETED
FG0004 subjects
FG0019 subjects
FG0023 subjects
FG00312 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0034 subjects
others
FG0003 subjects
FG0018 subjects
FG0021 subjects
FG0038 subjects
Single-Blind Extension (SBE) Period
Type
Comment
Milestone Data
STARTED
Among 114 participants completed initial treatment period, 96 participants entered SBE period
FG00017 subjects
FG00112 subjects
FG00238 subjects
FG00329 subjects
COMPLETED
Week 28-52 and additional 24 weeks(AT Day 1 -AT Week 24) for those retreated with active treatment
Participants who were PF-06651600 non-responders at Week 52 received PF-06700841, vice versa.
FG0005 subjects
FG0011 subjects
FG0028 subjects
FG003
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG003
All participants received at least 1 dose of PF-06651600,PF-06700841 or matching placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TP:Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
BG001
TP:PF-06651600
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.
BG002
TP:PF-06700841
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00047
BG00148
BG00247
BG003142
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.17± 14.22
BG00136.88± 12.62
BG00233.94± 11.43
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18-44 Years
Title
Measurements
BG00031
BG00133
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00137
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00045
BG00138
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
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 Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data at Week 24
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline, Week24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Title
Measurements
OG00032.54(25.35 to 39.74)
OG00150.59(43.15 to 58.02)
OG0021.41(-6.03 to 8.85)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Model Repeated Measure (MMRM)
MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
<.0001
Hochberg P-value (one-sided)
Mean of Difference from Placebo
31.14
Standard Error of the Mean
6.25
2-Sided
95
18.78
43.50
Superiority
Secondary
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
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.
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.
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
PF-06651600-AT/AU
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.
OG001
PF-06700841-AT/AU
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.
Primary
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
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.
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
Week 28 up to Week 52
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Placebo Non-responders on PF-06651600
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
Primary
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
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.
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
COE day 1 up to end of study
ID
Title
Description
OG000
COE-PF-06651600
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
OG001
COE-PF-06700841
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
Primary
Number of Participants With Laboratory Abnormalities During SBE Period
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.
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.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
Primary
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
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.
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.
Posted
Count of Participants
Participants
COE day 1 up to end of study
ID
Title
Description
OG000
COE-PF-06651600
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
OG001
Secondary
Percentage of Participants Achieving SALT 30 at 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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Week 24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
OG002
Placebo
Secondary
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
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.
"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.
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
OG002
Secondary
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
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.
"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.
Posted
Least Squares Mean
90% Confidence Interval
percent change
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline, Weeks 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
Secondary
Number of Participants With the IGA Score Change (Treatment Period)
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 analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.
Posted
Count of Participants
Participants
baseline, Week 2,4,6,8,12,16,20,24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Secondary
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period
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.
All participants who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) in Treatment Period.
Posted
Count of Participants
Participants
baseline up to Week 24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
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.
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Secondary
Number of Participants With Laboratory Abnormalities During Treatment Period
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.
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.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
PF-06651600
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.
OG001
PF-06700841
Secondary
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)
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.
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).
Posted
Number
95% Confidence Interval
Weeks
Week 24 up to Week 52
ID
Title
Description
OG000
PF-06651600 Responders
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)
OG001
PF-06700841 Responders
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)
Secondary
Change From Baseline in SALT Across Time (SBE Period)
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.
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.
Posted
Least Squares Mean
90% Confidence Interval
unit on a scale
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Secondary
Percentage of Participants Achieving SALT 30 Across Time (SBE Period)
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.
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.
Posted
Number
90% Confidence Interval
percent of participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Secondary
Percentage of Participants Achieving SALT 50 Across Time (SBE Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Secondary
Percentage of Participants Achieving SALT 75 Across Time (SBE Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Secondary
Percentage of Participants Achieving SALT 90 Across Time (SBE Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Secondary
Percentage of Participants Achieving SALT 100 Across Time (SBE Period)
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.
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.
Posted
Number
90% Confidence Interval
percentage of participants
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)
ID
Title
Description
OG000
Active Non-responders on PF-06651600
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
OG001
Active Non-responders on PF-06700841
Time Frame
From first dose of study treatment up to 113 weeks
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment Period-Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
0
47
0
47
26
47
EG001
Treatment Period-PF-06651600
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.
0
48
0
48
23
48
EG002
Treatment Period-PF-06700841
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.
0
47
2
47
28
47
EG003
Single Blind Extension-Active Non-responders on PF-06651600
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
0
16
0
16
8
16
EG004
Single Blind Extension-Placebo Non-responders on PF-06651600
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
0
17
0
17
12
17
EG005
Single Blind Extension-Active Non-responders on PF-06700841
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
0
5
0
5
4
5
EG006
Single Blind Extension-Placebo Non-responders on PF-06700841
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
0
12
0
12
10
12
EG007
SBE-Non-Retreated PF-06651600 Responders in 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) without entering the Retreatment Segment of the SBE Period
0
8
0
8
4
8
EG008
SBE-Retreated PF-06651600 Responders in 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.
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
0
9
0
9
6
9
EG010
SBE-Retreated PF-06700841 Responders in the Withdrawal Segment
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
0
14
0
14
9
14
EG011
SBE-Retreated PF-06651600 Responders in Retreatment 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
0
14
0
14
11
14
EG012
SBE-Retreated Responders on PF-06700841 in Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
0
15
1
15
8
15
EG013
Cross Over Extension-PF-06651600
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
0
5
0
5
4
5
EG014
Cross Over Extension-PF-06700841
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
0
18
1
18
8
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0022 affected47 at risk
EG0030 affected16 at risk
EG004
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0021 affected47 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acne
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected47 at risk
EG0015 affected48 at risk
EG0025 affected47 at risk
EG0030 affected16 at risk
EG0040 affected17 at risk
EG0050 affected5 at risk
EG0061 affected12 at risk
EG0070 affected8 at risk
EG0080 affected14 at risk
EG0090 affected9 at risk
EG0100 affected14 at risk
EG0110 affected14 at risk
EG0120 affected15 at risk
EG0130 affected5 at risk
EG0141 affected18 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0013 affected48 at risk
EG0021 affected47 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Papulopustular rosacea
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pseudofolliculitis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Urticaria papular
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
IgA nephropathy
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Aggression
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected47 at risk
EG0016 affected48 at risk
EG0024 affected47 at risk
EG003
Migraine
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Liver function test abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Liver function test increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected48 at risk
EG0023 affected47 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected47 at risk
EG0013 affected48 at risk
EG0021 affected47 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0006 affected47 at risk
EG0016 affected48 at risk
EG0024 affected47 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected47 at risk
EG0010 affected48 at risk
EG0023 affected47 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0005 affected47 at risk
EG0014 affected48 at risk
EG00211 affected47 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Viral infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0012 affected48 at risk
EG0023 affected47 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Inflammation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected47 at risk
EG0010 affected48 at risk
EG0021 affected47 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0023 affected47 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected47 at risk
EG0014 affected48 at risk
EG0021 affected47 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Lip oedema
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected47 at risk
EG0013 affected48 at risk
EG0023 affected47 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0023 affected47 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Influenza like illness
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Arthritis viral
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Ear infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Orchitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Blood potassium decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected48 at risk
EG0020 affected47 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
<.0001
Hochberg P-value (one-sided)
Mean of Difference from Placebo
49.18
Standard Error of the Mean
6.35
2-Sided
95
36.62
61.74
Superiority
OG002
Placebo-AT/AU
AT/AU Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
Units
Counts
Participants
OG00020
OG00122
OG00220
Title
Denominators
Categories
Title
Measurements
OG00027.59(15.24 to 39.94)
OG00148.42(36.38 to 60.47)
OG0021.81(-11.00 to 14.63)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Model Repeated Measure (MMRM)
MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
0.0094
Mean of Difference from Placebo
25.78
Standard Error of the Mean
10.64
2-Sided
90
7.98
43.58
Other
OG001
OG002
Mixed Model Repeated Measure
MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
<.0001
Mean of Difference from Placebo
46.61
Standard Error of the Mean
10.51
2-Sided
90
29.02
64.20
Other
OG002
Active Non-responders on PF-06700841
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Non-Retreated PF-06651600 Responders in the 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) without entering the Retreatment Segment of the SBE Period
OG005
Retreated PF-06651600 Responders in the 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. This arm stands for retreated responders with TEAE within withdrawal Segment
OG006
Non-Retreated PF-06700841 Responders in the 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
OG007
Retreated PF-06700841 Responders in the 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), 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
OG008
Retreated PF-06651600 Responders in the Retreatment 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
OG009
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG00117
OG0025
OG00312
OG0048
OG00514
OG0069
OG00714
OG00814
OG00915
Title
Denominators
Categories
TEAE (All Causalities)
Title
Measurements
OG0008
OG00112
OG0024
OG00310
OG0044
OG0053
OG0066
OG0079
OG00811
OG0099
TEAE (Treatment Related)
Title
Measurements
OG0005
OG0011
OG0020
OG003
Units
Counts
Participants
OG0005
OG00118
Title
Denominators
Categories
TEAE (All Causalities)
Title
Measurements
OG0004
OG0019
TEAE (Treatment Related)
Title
Measurements
OG0002
OG0013
OG001
Placebo Non-responders on PF-06651600
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
OG002
Active Non-responders on PF-06700841
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Non-Retreated PF-06651600 Responders in the 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) without entering the Retreatment Segment of the SBE Period
OG005
Retreated PF-06651600 Responders in the 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. This arm stands for retreated responders with TEAE within withdrawal Segment
OG006
Non-Retreated PF-06700841 Responders in the 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
OG007
Retreated PF-06700841 Responders in the 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), 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
OG008
Retreated PF-06651600 Responders in the Retreatment 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
OG009
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG00117
OG0025
OG00312
OG0048
OG00514
OG0069
OG00714
OG00814
OG00915
Title
Denominators
Categories
With abnormalities without regard to baseline
Title
Measurements
OG00013
OG00111
OG0024
OG00311
OG0046
OG0059
OG0067
OG00710
OG00811
OG00914
Meeting Retest Criteria
Title
Measurements
OG0003
OG0015
OG0022
OG003
Meeting Discontinuation Criteria
Title
Measurements
OG0000
OG0010
OG0020
OG003
COE-PF-06700841
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
Units
Counts
Participants
OG0005
OG00118
Title
Denominators
Categories
With abnormalities without regard to baseline
Title
Measurements
OG0005
OG00111
Meeting Retest Criteria
Title
Measurements
OG0001
OG0016
Meeting Discontinuation Criteria
Title
Measurements
OG0000
OG0010
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Title
Measurements
OG00050.0(37.6 to 62.4)
OG00163.8(51.3 to 74.9)
OG0022.1(0.2 to 8.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chan and Zhang method
<.0001
Difference in Percentage from Placebo
47.9
2-Sided
90
34.2
60.7
Other
OG001
OG002
Chan and Zhang method
<.0001
Difference in Percentage from Placebo
61.7
2-Sided
90
48.2
73.6
Other
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
Title
Measurements
OG000-0.74(-2.06 to 0.59)
OG001-0.93(-2.27 to 0.40)
OG0021.18(0.23 to 2.13)
Week 4
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
Title
Measurements
OG000
Week 6
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00243
Title
Measurements
OG000
Week 8
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
Title
Measurements
OG000
Week 12
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00245
Title
Measurements
OG000
Week 16
ParticipantsOG00045
ParticipantsOG00141
ParticipantsOG00242
Title
Measurements
OG000
Week 20
ParticipantsOG00045
ParticipantsOG00140
ParticipantsOG00240
Title
Measurements
OG000
Week 24
ParticipantsOG00044
ParticipantsOG00140
ParticipantsOG00235
Title
Measurements
OG000
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
Title
Measurements
OG000-0.76(-2.26 to 0.75)
OG001-1.13(-2.64 to 0.39)
OG0021.26(0.18 to 2.33)
Week 4
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
Title
Measurements
OG000
Week 6
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00243
Title
Measurements
OG000
Week 8
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
Title
Measurements
OG000
Week 12
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00245
Title
Measurements
OG000
Week 16
ParticipantsOG00045
ParticipantsOG00141
ParticipantsOG00242
Title
Measurements
OG000
Week 20
ParticipantsOG00045
ParticipantsOG00140
ParticipantsOG00240
Title
Measurements
OG000
Week 24
ParticipantsOG00044
ParticipantsOG00140
ParticipantsOG00235
Title
Measurements
OG000
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
Title
Measurements
OG000-2.1(-9.7 to 3.7)
OG001-2.1(-9.7 to 3.5)
OG0022.1(0.2 to 8.8)
Week 4
Title
Measurements
OG0006.2(-2.3 to 15.8)
OG00112.8(3.0 to 24.0)
OG0022.1(0.2 to 8.8)
Week 6
Title
Measurements
OG00018.7(7.0 to 31.0)
OG00127.7(15.4 to 40.4)
OG0022.1(0.2 to 8.8)
Week 8
Title
Measurements
OG00025.0(13.2 to 37.4)
OG00138.3(25.8 to 51.4)
OG0022.1(0.2 to 8.8)
Week 12
Title
Measurements
OG00039.5(26.4 to 52.6)
OG00148.9(35.8 to 61.8)
OG0022.1(0.2 to 8.8)
Week 16
Title
Measurements
OG00045.8(32.2 to 58.7)
OG00155.3(42.0 to 67.8)
OG0022.1(0.2 to 8.8)
Week 20
Title
Measurements
OG00047.9(34.2 to 60.7)
OG00159.6(46.3 to 71.7)
OG0022.1(0.2 to 8.8)
Week 24
Title
Measurements
OG00047.9(34.2 to 60.7)
OG00161.7(48.2 to 73.6)
OG0022.1(0.2 to 8.8)
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 4
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG00110.6(3.6 to 21.1)
OG0020(0.0 to 5.7)
Week 6
Title
Measurements
OG00010.4(1.1 to 21.1)
OG00117.0(6.5 to 28.8)
OG0022.1(0.2 to 8.8)
Week 8
Title
Measurements
OG00018.7(7.0 to 31.0)
OG00129.8(17.2 to 42.7)
OG0022.1(0.2 to 8.8)
Week 12
Title
Measurements
OG00027.0(15.0 to 39.6)
OG00136.2(23.8 to 49.2)
OG0022.1(0.2 to 8.8)
Week 16
Title
Measurements
OG00033.3(20.3 to 46.2)
OG00140.4(27.8 to 53.5)
OG0022.1(0.2 to 8.8)
Week 20
Title
Measurements
OG00033.3(20.3 to 46.2)
OG00146.8(33.8 to 59.8)
OG0022.1(0.2 to 8.8)
Week 24
Title
Measurements
OG00037.5(24.5 to 50.6)
OG00151.1(37.9 to 63.8)
OG0022.1(0.2 to 8.8)
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 4
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 6
Title
Measurements
OG0008.3(1.8 to 18.1)
OG00110.6(3.6 to 21.1)
OG0020(0.0 to 5.7)
Week 8
Title
Measurements
OG00012.5(2.8 to 23.6)
OG00123.4(11.8 to 36.2)
OG0022.1(0.2 to 8.8)
Week 12
Title
Measurements
OG00016.6(6.3 to 28.6)
OG00127.7(15.4 to 40.4)
OG0022.1(0.2 to 8.8)
Week 16
Title
Measurements
OG00020.8(8.6 to 33.0)
OG00131.9(19.0 to 44.9)
OG0022.1(0.2 to 8.8)
Week 20
Title
Measurements
OG00025.0(13.2 to 37.4)
OG00138.3(25.8 to 51.4)
OG0022.1(0.2 to 8.8)
Week 24
Title
Measurements
OG00027.0(15.0 to 39.6)
OG00140.4(27.8 to 53.5)
OG0022.1(0.2 to 8.8)
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 4
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 6
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0016.4(0.2 to 15.7)
OG0020(0.0 to 5.7)
Week 8
Title
Measurements
OG0004.2(-2.0 to 12.5)
OG00112.8(5.2 to 23.6)
OG0020(0.0 to 5.7)
Week 12
Title
Measurements
OG00010.4(3.4 to 20.7)
OG00125.5(15.4 to 38.1)
OG0020(0.0 to 5.7)
Week 16
Title
Measurements
OG00016.7(8.6 to 27.7)
OG00127.7(17.2 to 40.3)
OG0020(0.0 to 5.7)
Week 20
Title
Measurements
OG00018.7(7.0 to 31.0)
OG00129.8(17.2 to 42.7)
OG0022.1(0.2 to 8.8)
Week 24
Title
Measurements
OG00025.0(15.1 to 37.3)
OG00134.0(22.7 to 47.0)
OG0020(0.0 to 5.7)
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 4
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 6
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0010.0(-6.2 to 6.2)
OG0020(0.0 to 5.7)
Week 8
Title
Measurements
OG0000.0(-6.2 to 6.1)
OG0012.1(-3.5 to 9.7)
OG0020(0.0 to 5.7)
Week 12
Title
Measurements
OG0002.1(-3.8 to 9.5)
OG0016.4(0.2 to 15.7)
OG0020(0.0 to 5.7)
Week 16
Title
Measurements
OG0002.1(-3.8 to 9.5)
OG0018.5(1.9 to 18.4)
OG0020(0.0 to 5.7)
Week 20
Title
Measurements
OG0004.2(-2.0 to 12.5)
OG00112.8(5.2 to 23.6)
OG0020(0.0 to 5.7)
Week 24
Title
Measurements
OG00012.5(5.1 to 23.2)
OG00112.8(5.2 to 23.6)
OG0020(0.0 to 5.7)
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
Baseline
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00247
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG00048
OG00147
OG00247
1 (1-24% REGROWTH)
OG0000
OG0010
OG0020
2 (25-49% REGROWTH)
OG0000
OG0010
OG0020
3 (50-74% REGROWTH)
OG0000
OG0010
OG0020
4 (75-99% REGROWTH)
OG0000
OG0010
OG0020
5 (100% REGROWTH)
OG0000
OG0010
OG0020
Week 2
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 4
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00243
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 6
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00243
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 8
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00244
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 12
ParticipantsOG00047
ParticipantsOG00144
ParticipantsOG00245
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 16
ParticipantsOG00045
ParticipantsOG00141
ParticipantsOG00242
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 20
ParticipantsOG00045
ParticipantsOG00140
ParticipantsOG00240
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Week 24
ParticipantsOG00044
ParticipantsOG00140
ParticipantsOG00235
Title
Measurements
0 (NO CHANGE OR FURTHER LOSS)
OG000
Units
Counts
Participants
OG00048
OG00147
OG00247
Title
Denominators
Categories
TEAE (All Causalities)
Title
Measurements
OG00032
OG00136
OG00235
TEAE (Treatment Related)
Title
Measurements
OG00013
OG00120
OG00214
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.
OG002
Placebo
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Units
Counts
Participants
OG00048
OG00147
OG00246
Title
Denominators
Categories
With abnormalities without regard to baseline
Title
Measurements
OG00035
OG00136
OG00232
Meeting Safety Criteria
Title
Measurements
OG00012
OG00129
OG0025
Meeting Retest Criteria
Title
Measurements
OG0005
OG00118
OG0029
Meeting Discontinuation Criteria
Title
Measurements
OG0000
OG0013
OG0020
Units
Counts
Participants
OG00022
OG00124
Title
Denominators
Categories
Q1 time to retreatment (25th percentile of time)
Title
Measurements
OG00010.1(4.3 to 12.6)
OG00111.0(4.1 to 16.1)
Median time to retreatment
Title
Measurements
OG00016.1(10.1 to 20.3)
OG00124.1(14.6 to NA)NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the median time to retreatment (ie. 50% of participants meeting the criterion).
Q3 time to retreatment (75th percentile of time)
Title
Measurements
OG00021.1(16.1 to NA)NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the Q3 time to retreatment (ie. 75% of participants meeting the criterion).
OG001NA(24.3 to NA)NA indicates not estimable. The withdrawal segment is not lengthy enough to observe Q3 time to retreatment (ie. 75% of participants meeting the criterion) and corresponding upper limit of the 95% CI.
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG0015
OG00217
OG00312
OG00414
OG00515
Title
Denominators
Categories
Week 30/ AT Week 2
ParticipantsOG00015
ParticipantsOG0015
ParticipantsOG00216
ParticipantsOG00310
ParticipantsOG00413
ParticipantsOG00514
Title
Measurements
OG0001.76(-4.47 to 7.99)
OG0010.09(-9.83 to 10.01)
OG0022.99(-4.56 to 10.54)
OG003
Week 32/ AT Week 4
ParticipantsOG00016
ParticipantsOG0014
ParticipantsOG00217
ParticipantsOG00312
Week 34/ AT Week 6
ParticipantsOG00016
ParticipantsOG0014
ParticipantsOG00216
ParticipantsOG00312
Week 36/ AT Week 8
ParticipantsOG00014
ParticipantsOG0014
ParticipantsOG00216
ParticipantsOG00311
Week 40/ AT Week 12
ParticipantsOG00013
ParticipantsOG0014
ParticipantsOG00216
ParticipantsOG00312
Week 44/ AT Week 16
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG00311
Week 48/ AT Week 20
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Week 52/ AT Week 24
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00212
ParticipantsOG00311
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG0015
OG00217
OG00312
OG00414
OG00515
Title
Denominators
Categories
Week 30/ AT Week 2
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG0023.8(-5.5 to 21.6)
OG003-2.1(-9.7 to 18.9)
OG00447.9(25.3 to 70.0)
OG00531.2(12.8 to 54.0)
Week 32/ AT Week 4
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG0029.6(-2.4 to 30.2)
OG003
Week 34/ AT Week 6
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG00221.4(4.8 to 43.2)
OG003
Week 36/ AT Week 8
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG00221.4(4.8 to 43.2)
OG003
Week 40/ AT Week 12
Title
Measurements
OG00010.4(-1.5 to 31.8)
OG001-2.1(-10.9 to 40.0)
OG00227.3(8.5 to 49.6)
OG003
Week 44/ AT Week 16
Title
Measurements
OG00010.4(-1.5 to 31.8)
OG001-2.1(-10.9 to 40.0)
OG00233.2(15.2 to 54.5)
OG003
Week 48/ AT Week 20
Title
Measurements
OG00010.4(-1.5 to 31.8)
OG001-2.1(-10.9 to 40.0)
OG00239.0(20.0 to 60.1)
OG003
Week 52/ AT Week 24
Title
Measurements
OG00010.4(-1.5 to 31.8)
OG001-2.1(-10.9 to 40.0)
OG00227.3(8.5 to 49.6)
OG003
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG0015
OG00217
OG00312
OG00414
OG00515
Title
Denominators
Categories
Week 30/ AT Week 2
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG0030.0(-6.3 to 22.1)
OG00414.3(2.4 to 38.5)
OG00520.0(5.7 to 44.0)
Week 32/ AT Week 4
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 34/ AT Week 6
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG0029.6(-2.4 to 30.2)
OG003
Week 36/ AT Week 8
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG0023.8(-5.5 to 21.6)
OG003
Week 40/ AT Week 12
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG00215.5(1.1 to 36.8)
OG003
Week 44/ AT Week 16
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG00221.4(4.8 to 43.2)
OG003
Week 48/ AT Week 20
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG00227.3(8.5 to 49.6)
OG003
Week 52/ AT Week 24
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG00227.3(8.5 to 49.6)
OG003
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG0015
OG00217
OG00312
OG00414
OG00515
Title
Denominators
Categories
Week 30/ AT Week 2
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG0030.0(-6.3 to 22.1)
OG0040.0(-6.8 to 19.3)
OG0050.0(-6.6 to 18.1)
Week 32/ AT Week 4
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 34/ AT Week 6
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 36/ AT Week 8
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG002-2.1(-9.7 to 13.3)
OG003
Week 40/ AT Week 12
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG0023.8(-5.5 to 21.6)
OG003
Week 44/ AT Week 16
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG00215.5(1.1 to 36.8)
OG003
Week 48/ AT Week 20
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG00215.5(1.1 to 36.8)
OG003
Week 52/ AT Week 24
Title
Measurements
OG0004.1(-5.3 to 23.0)
OG001-2.1(-10.9 to 40.0)
OG00227.3(8.5 to 49.6)
OG003
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Units
Counts
Participants
OG00016
OG0015
OG00217
OG00312
OG00414
OG00515
Title
Denominators
Categories
Week 30/ AT Week 2
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG0030.0(-6.3 to 22.1)
OG0040.0(-6.8 to 19.3)
OG0050.0(-6.6 to 18.1)
Week 32/ AT Week 4
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 34/ AT Week 6
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 36/ AT Week 8
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 40/ AT Week 12
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 44/ AT Week 16
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG0020.0(-6.2 to 16.2)
OG003
Week 48/ AT Week 20
Title
Measurements
OG000-2.1(-9.7 to 13.8)
OG001-2.1(-10.9 to 40.0)
OG0023.8(-5.5 to 21.6)
OG003
Week 52/ AT Week 24
Title
Measurements
OG0000.0(-6.3 to 17.1)
OG0010.0(-7.4 to 45.1)
OG00217.6(5.0 to 39.6)
OG003
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
OG002
Placebo Non-responders on PF-06651600
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
OG003
Placebo Non-responders on PF-06700841
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
OG004
Retreated PF-06651600 Responders in the Retreatment 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
OG005
Retreated Responders on PF-06700841 in the Retreatment 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), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841