A Phase 2b Study To Evaluate The Efficacy And Safety Prof... | NCT03715829 | Trialant
NCT03715829
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 25, 2022Actual
Enrollment
366Actual
Phase
Phase 2
Conditions
Active Non-segmental Vitiligo
Interventions
PF-06651600
PF-06651600
PF-06651600
PF-06651600
PF-06651600
placebo
PF06700841
narrow-band UVB phototherapy
Countries
United States
Australia
Belgium
Canada
Germany
Italy
Japan
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03715829
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7981019
Secondary IDs
ID
Type
Description
Link
2018-001271-20
EudraCT Number
Brief Title
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Official Title
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2022
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
Nov 26, 2018Actual
Primary Completion Date
Feb 5, 2021Actual
Completion Date
Feb 5, 2021Actual
First Submitted Date
Oct 19, 2018
First Submission Date that Met QC Criteria
Oct 19, 2018
First Posted Date
Oct 23, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 10, 2022
Results First Submitted that Met QC Criteria
Mar 1, 2022
Results First Posted Date
Mar 25, 2022Actual
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
Mar 1, 2022
Last Update Posted Date
Mar 25, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.
Detailed Description
Not provided
Conditions Module
Conditions
Active Non-segmental Vitiligo
Keywords
Not provided
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
366Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks
Drug: PF-06651600
Cohort 2
Experimental
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
Drug: PF-06651600
Cohort 3
Experimental
Maintenance dose A given QD for 24 weeks
Drug: PF-06651600
Cohort 4
Experimental
Maintenance dose B given QD for 24 weeks
Drug: PF-06651600
Cohort 5
Experimental
Maintenance dose C given QD for 24 weeks
Drug: PF-06651600
Cohort 6
Placebo Comparator
Placebo given QD for 24 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06651600
Drug
Induction dose 1. Oral tablet taken QD
Cohort 1
Extension Cohort 2
Extension Cohort 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Central read F-VASI was assessed based on the facial photographs taken at the site. Central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. The higher score of F-VASI signified severer symptoms of non-segmental vitiligo. Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. A negative percent change from baseline in central read F-VASI signified an improvement.
Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Adverse Event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
24 weeks
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
This outcome measure was the percentage of participants achieving at least 75% improvement from baseline in central read F-VASI (F-VASI75) at Week 24. A negative percent change from baseline in central read F-VASI signified an improvement. The central read F-VASI75 response rate was analyzed by first treating the missing data (non-COVID-19 related) as non responders and then applying Chan and Zhang exact confidence interval (CI) method at Week 24.
Central read F-VASI75=1 if percent change from baseline ≥75; central read F-VASI75=0 if percent change from baseline <75. Percent change from baseline in F-VASI=((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. Baseline was defined as the last measurement prior to study Day 18.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
Must have moderate to severe active non-segmental vitiligo.
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)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 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
Marvel Research, LLC
Huntington Beach
California
92647
United States
University of California, Irvine, Dermatology Clinical Research Center
Chen Y, Lukic T, Chen AS, Adiri R, Tran H, Schaefer G, Ghosh P, Madhavan S, Soma K, Gamalo M. Automated Measurement of Depigmentation Extent with a New AI Tool Applied to the Example of Vitiligo. Dermatol Ther (Heidelb). 2026 Jun;16(6):3139-3149. doi: 10.1007/s13555-026-01736-8. Epub 2026 May 4.
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.
A total of 578 participants were screened for this study; 366 were randomized to treatment and 364 (99.5%) received treatment in the Dose Ranging Period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
FG001
PF-06651600 100 mg - 50 mg QD
Periods
Title
Milestones
Reasons Not Completed
Dose Ranging Period
Type
Comment
Milestone Data
STARTED
The first 6 treatment groups entered this Dose Ranging Period.
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 26, 2020
Jan 10, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Dose ranging period is a parallel design. Extension period is a sequential design.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: placebo
Extension Cohort 1
Experimental
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
Drug: PF06700841
Extension Cohort 2
Experimental
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy
Drug: PF-06651600
Device: narrow-band UVB phototherapy
Extension Cohort 3
Experimental
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
Drug: PF-06651600
Extension Cohort 4
Experimental
Maintenance dose A given QD for 24 weeks
Drug: PF-06651600
Extension Cohort 5
Experimental
Maintenance dose B given QD for 24 weeks
Drug: PF-06651600
Extension Cohort 6
No Intervention
Observation period for 24 weeks
PF-06651600
Drug
Induction dose 2. Oral tablet taken QD
Cohort 2
PF-06651600
Drug
Maintenance dose A. Oral tablet taken QD
Cohort 1
Cohort 2
Cohort 3
Extension Cohort 2
Extension Cohort 3
Extension Cohort 4
PF-06651600
Drug
Maintenance Dose B. Oral tablet taken QD
Cohort 4
Extension Cohort 5
PF-06651600
Drug
Maintenance Dose C. Oral tablet taken QD
Cohort 5
placebo
Drug
placebo
Cohort 6
PF06700841
Drug
Oral tablet taken QD
Extension Cohort 1
narrow-band UVB phototherapy
Device
Phototherapy will be combined with PF-06651600
Extension Cohort 2
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.
An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline up to Week 24
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline up to Week 24
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
24 weeks
Number of Participants With TEAEs and SAEs - Extension (Ext) Period
AE was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
24 weeks
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.
An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
24 weeks
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
24 Weeks
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
24 weeks
Week 24
Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Total body VASI (T-VASI) was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI= Ʃ[Hand Units]×[Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The extent of depigmentation was expressed by percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The data below was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50) at Week 24. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Week 24
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
The central read F-VASI was assessed based on the facial photographs taken at the site. The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area.
Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Baseline, Weeks 4, 8, 16 and 24
Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0.00 4.00): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.
Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
The Self-Assessment Vitiligo Extent Score (SA-VES) was a validated patient report outcome measurement instrument to provide information about disease extent. Vitiligo Extent Score (VES) was a measure to express the overall vitiligo involvement of the body (extent). Clinical illustrations for 19 separate body areas that reflected different degrees of involvement (1%, 5%, 10%, 25%, 50% and 75% depigmentation) were chosen to represent the participant's skin lesions to get the total extent of the disease. VES was a sum of all surface measurement that was similar to VASI. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 16 and 24
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.
The absolute change from baseline in T-VASI was analyzed using the ANCOVA analysis. Negative change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 75% improvement from baseline in T-VASI (T-VASI75). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 90% improvement from baseline in T-VASI (T-VASI90). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
T-VASI was calculated using a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This outcome measure was the percentage of participants achieving 100% improvement from baseline in T-VASI (T-VASI100). Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in central read F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in central read F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in central read F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 100% improvement in central read F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in site assessment F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in site assessment F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in site assessment F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving 100% improvement in site assessment F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
The Vitiligo-Specific Quality of Life (VitiQoL) instrument was a reliable and validated vitiligo disease-specific health-related quality of life (HRQoL) instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL total score was calculated as sum of items 1-15.
The change from baseline in total VitiQoL score was analyzed using the mixed-effect models repeated measures (MMRM) analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 16 and 24
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Participation Limitation domain score was the sum of items 3, 4, 6, 9, 10, 11, 14 and ranged from 0 to 42.
The change from baseline in VitiQoL Participation Limitation Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 16 and 24
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Stigma domain score was the sum of items 1, 2, 5, 7 and 15, and ranged from 0 to 30.
The change from baseline in VitiQoL Stigma Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 16 and 24
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Behaviors domain score was the sum of items 8, 12 and 13, and ranged from 0 to 18.
The change from baseline in VitiQoL Behaviors Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline, Weeks 4, 16 and 24
Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
The percentage of participants achieving a static Investigator Global Assessment (sIGA) Score 0/1 and sIGA ≥2-point improvement at Week 24 was presented in this outcome measure. The sIGA score ranged from 0 to 4.
The sIGA Score 0 represented "Clear" with no signs of loss of pigmentation with natural light or with Woods lamp examination.
The sIGA Score 1 represented "Almost Clear" with the following descriptors:
Faint, barely detectable loss of pigmentation mainly located on dorsal hands, feet, bony prominences, and/or limited areas.
Approximately 90% pigmentation within lesions.
No or rare signs of Koebner phenomenon, confetti like or trichrome lesions could be present.
The sIGA Scores 2, 3 and 4 represented "Mild Vitiligo", "Moderate Vitiligo" and "Severe Vitiligo", respectively.
Week 24
Irvine
California
92697
United States
Vitiligo and Pigmentation Institute Of Southern California
Los Angeles
California
90036
United States
Dermatology Specialist, Inc.
Murrieta
California
92562
United States
Dermatology Specialists, Inc.
Oceanside
California
92056
United States
UC Davis Health
Sacramento
California
95816
United States
Brookside Dermatology Associates
Bridgeport
Connecticut
06606
United States
New England Research Associates, LLC
Bridgeport
Connecticut
06606
United States
New Horizon Research Center
Miami
Florida
33165
United States
Park Avenue Dermatology
Orange Park
Florida
32073
United States
ForCare Clinical Research
Tampa
Florida
33613
United States
Advanced Skin and MOHS Surgery Center, c/o TrialSpark, Inc.
Chicago
Illinois
60657
United States
Chevy Chase Dermatology Center (TrialSpark, Inc.)
Chevy Chase
Maryland
20815
United States
TrialSpark - Samantha Toerge, MD
Chevy Chase
Maryland
20815
United States
TrialSpark - Ronald Shore, MD
Rockville
Maryland
20852
United States
Tobias & Battite, Inc.
Boston
Massachusetts
02111
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
UMass Memorial Medical Center, Hahnemann Campus
Worcester
Massachusetts
01605
United States
Investigational Drug Service Pharmacy
Worcester
Massachusetts
01655
United States
UMass Memorial Medical Center Ear Nose and Throat
Worcester
Massachusetts
01655
United States
University of Massachusetts Medical School
Worcester
Massachusetts
01655
United States
Henry Ford Hospital Department of Dermatology
Detroit
Michigan
48202
United States
University of Minnesota Department of Dermatology
Minneapolis
Minnesota
55455
United States
The Dermatology Group, P.C.
Verona
New Jersey
07044
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10003
United States
Upper West Side Dermatology c/o TrialSpark, Inc
New York
New York
10023
United States
MDCS: Medical Dermatology & Cosmetic Surgery (TrialSpark, Inc.)
New York
New York
10065
United States
South Nassau Dermatology
Oceanside
New York
11572
United States
TrialSpark, Inc. - Russell W. Cohen, MD
Oceanside
New York
11572
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28411
United States
Remington-Davis, Inc. Clinical Research
Columbus
Ohio
43215
United States
ForeFront Dermatology
Columbus
Ohio
43220
United States
Vital Prospects Clinical Research Institute, PC
Tulsa
Oklahoma
74136
United States
University Physicians Group
Austin
Texas
78701
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390-9191
United States
Pickens Academic Tower
Houston
Texas
77030
United States
The University of Texas Health Science Center at Houston
Houston
Texas
77030
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Virginia Clinical Research, Inc
Norfolk
Virginia
23502
United States
Tamjidi Skin Institute (TrialSpark, Inc.)
Vienna
Virginia
22182
United States
The Skin Hospital
Darlinghurst
New South Wales
2010
Australia
Premier Specialists Pty Ltd
Kogarah
New South Wales
2217
Australia
Veracity Clinical Research Pty Ltd
Woolloongabba
Queensland
4102
Australia
Skin Health Institute
Carlton
Victoria
3053
Australia
Sinclair Dermatology
East Melbourne
Victoria
3002
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3052
Australia
Hôpital Erasme Dermatology
Brussels
1070
Belgium
UZ Brussel - Dermatology
Brussels
1090
Belgium
UZ Gent - Dermatology
Ghent
9000
Belgium
Dr. Chih-ho Hong Medical Inc.
Surrey
British Columbia
V3R 6A7
Canada
Enverus Medical Research
Surrey
British Columbia
V3V 0C6
Canada
University of British Columbia
Vancouver
British Columbia
V5Z 4E8
Canada
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
CCA Medical Research
Ajax
Ontario
L1S 7K8
Canada
Guenther Research Inc.
London
Ontario
N6A 3H7
Canada
Lynderm Research Inc.
Markham
Ontario
L3P 1X3
Canada
DermEdge Research
Mississauga
Ontario
L5H 1G9
Canada
North York Research Inc.
North York
Ontario
M2M 4J5
Canada
The Centre for Clinical Trials
Oakville
Ontario
L6J 7W5
Canada
The Centre for Dermatology
Richmond Hill
Ontario
L4B 1A5
Canada
K.Papp Clinical Research
Waterloo
Ontario
N2J 1C4
Canada
Innovaderm Research Inc.
Montreal
Quebec
H2X 2V1
Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec
Quebec
G1V 4X7
Canada
Centre de Recherche Saint-Louis
Québec
Quebec
G1W 4R4
Canada
Centre de Recherche Saint-Louis
Québec
Quebec
G1W1S2
Canada
Diex Research Sherbrooke Inc.
Sherbrooke
Quebec
J1L 0H8
Canada
Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
55131
Germany
Universitaetsklinikum Muenster
Münster
48149
Germany
Istituti Fisioterapici Ospitalieri, Istituto di Ricovero e Cura a Carattere Scientifico,
Roma
RM
00144
Italy
Nagoya City University Hospital - Dermatology
Nagoya
Aichi-ken
467-8602
Japan
Tohoku University Hospital
Sendai
Miyagi
980-8574
Japan
Nippon Medical School Hospital
Bunkyo-ku
Tokyo
113-8603
Japan
Tokyo Medical University Hospital
Shinjuku-ku
Tokyo
160-0023
Japan
Yamanashi Prefectural Central Hospital
Kofu
Yamanashi
400-8506
Japan
Dongguk University Ilsan Hospital
Goyang-si
Gyeonggi-do
10326
South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Gyeonggi-do
16247
South Korea
Ajou University Hospital
Suwon
Gyeonggi-do
16499
South Korea
Inha University Hospital
Incheon
22332
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona
08041
Spain
Hospital Universitario Reina Sofia
Córdoba
14004
Spain
Hospital Universitario Ramón y Cajal
Madrid
28034
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Hospital Universitari i Politecnic La Fe
Valencia
46026
Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
83301
Taiwan
National Cheng Kung University Hospital
Tainan
70403
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Yamaguchi Y, Peeva E, Duca ED, Facheris P, Bar J, Shore R, Cox LA, Sloan A, Thaci D, Ganesan A, Han G, Ezzedine K, Ye Z, Guttman-Yassky E. Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligo. Arch Dermatol Res. 2024 Jul 18;316(7):478. doi: 10.1007/s00403-024-03182-y.
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.
Guttman-Yassky E, Del Duca E, Da Rosa JC, Bar J, Ezzedine K, Ye Z, He W, Hyde C, Hassan-Zahraee M, Yamaguchi Y, Peeva E. Improvements in immune/melanocyte biomarkers with JAK3/TEC family kinase inhibitor ritlecitinib in vitiligo. J Allergy Clin Immunol. 2024 Jan;153(1):161-172.e8. doi: 10.1016/j.jaci.2023.09.021. Epub 2023 Sep 28.
Ezzedine K, Peeva E, Yamaguchi Y, Cox LA, Banerjee A, Han G, Hamzavi I, Ganesan AK, Picardo M, Thaci D, Harris JE, Bae JM, Tsukamoto K, Sinclair R, Pandya AG, Sloan A, Yu D, Gandhi K, Vincent MS, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
FG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
FG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
FG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
FG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
FG006
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
FG007
EXT PF-06651600 200 Mg-50 mg QD + nbUVB
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
FG008
EXT PF-06651600 200 mg - 50 mg QD
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
FG009
EXT PF-06651600 50 mg QD
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
FG010
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
FG00065 subjects
FG00167 subjects
FG00267 subjects
FG00350 subjects
FG00449 subjects
FG00566 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00053 subjects
FG00158 subjects
FG00254 subjects
FG00336 subjects
FG00442 subjects
FG00555 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00012 subjects
FG0019 subjects
FG00213 subjects
FG00314 subjects
FG0047 subjects
FG00511 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0014 subjects
FG0025 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0014 subjects
FG0023 subjects
FG0039 subjects
FG004
Medication Error Without Associated Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
No Longer Meets Eligibility Criteria
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Extension Period
Type
Comment
Milestone Data
STARTED
The last 5 EXT treatment groups entered this Extension Period.
Three participants were lost to follow-up after completing the Dose Ranging Period, and no extension treatment was recorded for these 3 participants. A total of 295 participants were assigned to the Extension Period, among whom 293 received treatment.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00655 subjects
FG00743 subjects
FG008187 subjects
FG0096 subjects
FG0102 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
BG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
BG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
BG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
BG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
BG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00167
BG00267
BG00350
BG00449
BG00566
BG006364
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18 Years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00131
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG0019
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Central read F-VASI was assessed based on the facial photographs taken at the site. Central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. The higher score of F-VASI signified severer symptoms of non-segmental vitiligo. Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. A negative percent change from baseline in central read F-VASI signified an improvement.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
ID
Title
Description
OG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.2± 4.13
OG001-21.2± 4.16
OG002-18.5± 4.44
OG003
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
OG005
ANCOVA
<0.0001
Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Least Squares Mean Difference (Net)
-23.2
Standard Error of the Mean
5.62
2-Sided
90
-32.53
-13.96
Superiority
Secondary
Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
This outcome measure was the percentage of participants achieving at least 75% improvement from baseline in central read F-VASI (F-VASI75) at Week 24. A negative percent change from baseline in central read F-VASI signified an improvement. The central read F-VASI75 response rate was analyzed by first treating the missing data (non-COVID-19 related) as non responders and then applying Chan and Zhang exact confidence interval (CI) method at Week 24.
Central read F-VASI75=1 if percent change from baseline ≥75; central read F-VASI75=0 if percent change from baseline <75. Percent change from baseline in F-VASI=((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. Baseline was defined as the last measurement prior to study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG001
PF-06651600 100 mg - 50 mg QD
Secondary
Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Total body VASI (T-VASI) was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI= Ʃ[Hand Units]×[Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The extent of depigmentation was expressed by percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The data below was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50) at Week 24. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
The central read F-VASI was assessed based on the facial photographs taken at the site. The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area.
Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Weeks 4, 8, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0.00 4.00): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.
Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
The Self-Assessment Vitiligo Extent Score (SA-VES) was a validated patient report outcome measurement instrument to provide information about disease extent. Vitiligo Extent Score (VES) was a measure to express the overall vitiligo involvement of the body (extent). Clinical illustrations for 19 separate body areas that reflected different degrees of involvement (1%, 5%, 10%, 25%, 50% and 75% depigmentation) were chosen to represent the participant's skin lesions to get the total extent of the disease. VES was a sum of all surface measurement that was similar to VASI. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Weeks 4, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
PF-06651600 100 mg - 50 mg QD
Secondary
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.
The absolute change from baseline in T-VASI was analyzed using the ANCOVA analysis. Negative change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and have a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 75% improvement from baseline in T-VASI (T-VASI75). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 90% improvement from baseline in T-VASI (T-VASI90). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
T-VASI was calculated using a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This outcome measure was the percentage of participants achieving 100% improvement from baseline in T-VASI (T-VASI100). Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in central read F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in central read F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in central read F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 100% improvement in central read F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in site assessment F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in site assessment F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in site assessment F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving 100% improvement in site assessment F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Number
Percentage of Participants
Baseline, Weeks 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
The Vitiligo-Specific Quality of Life (VitiQoL) instrument was a reliable and validated vitiligo disease-specific health-related quality of life (HRQoL) instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL total score was calculated as sum of items 1-15.
The change from baseline in total VitiQoL score was analyzed using the mixed-effect models repeated measures (MMRM) analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Weeks 4, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Secondary
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Participation Limitation domain score was the sum of items 3, 4, 6, 9, 10, 11, 14 and ranged from 0 to 42.
The change from baseline in VitiQoL Participation Limitation Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Weeks 4, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
Secondary
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Stigma domain score was the sum of items 1, 2, 5, 7 and 15, and ranged from 0 to 30.
The change from baseline in VitiQoL Stigma Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Weeks 4, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
PF-06651600 100 mg - 50 mg QD
Secondary
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Behaviors domain score was the sum of items 8, 12 and 13, and ranged from 0 to 18.
The change from baseline in VitiQoL Behaviors Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Weeks 4, 16 and 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
Secondary
Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
The percentage of participants achieving a static Investigator Global Assessment (sIGA) Score 0/1 and sIGA ≥2-point improvement at Week 24 was presented in this outcome measure. The sIGA score ranged from 0 to 4.
The sIGA Score 0 represented "Clear" with no signs of loss of pigmentation with natural light or with Woods lamp examination.
The sIGA Score 1 represented "Almost Clear" with the following descriptors:
Faint, barely detectable loss of pigmentation mainly located on dorsal hands, feet, bony prominences, and/or limited areas.
Approximately 90% pigmentation within lesions.
No or rare signs of Koebner phenomenon, confetti like or trichrome lesions could be present.
The sIGA Scores 2, 3 and 4 represented "Mild Vitiligo", "Moderate Vitiligo" and "Severe Vitiligo", respectively.
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
PF-06651600 100 mg - 50 mg QD
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Adverse Event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG001
PF-06651600 100 mg - 50 mg QD
Primary
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.
An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Baseline was defined as the last measurement prior to first dosing (Day 1).
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
PF-06651600 200mg - 50mg QD
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Primary
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
Baseline was defined as the last measurement prior to first dosing (Day 1).
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Primary
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Primary
Number of Participants With TEAEs and SAEs - Extension (Ext) Period
AE was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
OG001
EXT PF-06651600 200 Mg-50 mg QD + nbUVB
Primary
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.
An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
OG001
EXT PF-06651600 200 Mg-50 mg QD + nbUVB
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Primary
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
The safety analysis population included all participants who received at least 1 dose of investigational product.
Posted
Count of Participants
Participants
24 Weeks
ID
Title
Description
OG000
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
OG001
EXT PF-06651600 200 Mg-50 mg QD + nbUVB
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Primary
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
The safety analysis population included all participants who received at least 1 dose of investigational product. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
OG001
EXT PF-06651600 200 Mg-50 mg QD + nbUVB
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
OG002
Time Frame
48 weeks
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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
PF-06651600 200 mg - 50 mg QD
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
0
65
0
65
31
65
EG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
0
67
0
67
35
67
EG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
0
67
1
67
32
67
EG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
0
50
1
50
23
50
EG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
0
49
1
49
22
49
EG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
0
66
1
66
37
66
EG006
Extension (EXT) PF-06700841 60 mg - 30 mg QD
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
0
55
1
55
17
55
EG007
EX PF-06651600 200 mg - 50 mg QD + nbUVB
Induction dose of PF-06651600 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by maintenance dosing of PF-06651600 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provide nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label.
0
43
0
43
14
43
EG008
EX PF-06651600 200mg-50mg QD
Induction dose of 200 mg QD of PF 06651600 for 4 weeks followed by maintenance dosing of 50 mg QD of PF 06651600 for 20 weeks. This arm is double blinded.
0
187
1
187
46
187
EG009
EX PF-06651600 50mg QD
50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.
0
6
0
6
3
6
EG010
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Oesophageal spasm
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG0031 events1 affected50 at risk
EG0040 events0 affected49 at risk
EG0050 events0 affected66 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected187 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected2 at risk
Migraine
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected67 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Disseminated varicella zoster virus infection
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected67 at risk
EG0023 events2 affected67 at risk
EG0030 events0 affected50 at risk
EG0041 events1 affected49 at risk
EG0054 events4 affected66 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected187 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0017 events5 affected67 at risk
EG0022 events2 affected67 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0006 events6 affected65 at risk
EG0011 events1 affected67 at risk
EG0022 events2 affected67 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected67 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0012 events1 affected67 at risk
EG0021 events1 affected67 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0002 events2 affected65 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected67 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0009 events8 affected65 at risk
EG00111 events10 affected67 at risk
EG00220 events16 affected67 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0006 events5 affected65 at risk
EG00111 events10 affected67 at risk
EG0028 events5 affected67 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0005 events4 affected65 at risk
EG0016 events4 affected67 at risk
EG0022 events2 affected67 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0003 events3 affected65 at risk
EG0013 events3 affected67 at risk
EG0028 events6 affected67 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0004 events4 affected65 at risk
EG0019 events7 affected67 at risk
EG0028 events8 affected67 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0004 events4 affected65 at risk
EG0011 events1 affected67 at risk
EG0024 events4 affected67 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected65 at risk
EG0014 events4 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0003 events3 affected65 at risk
EG0012 events2 affected67 at risk
EG0022 events2 affected67 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0003 events2 affected65 at risk
EG0016 events3 affected67 at risk
EG0021 events1 affected67 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Spinal segmental dysfunction
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected67 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected67 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.
Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Least Squares Mean Difference (Net)
-23.2
Standard Error of the Mean
5.63
2-Sided
90
-32.53
-13.93
Superiority
OG002
OG005
ANCOVA
0.0003
Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Least Squares Mean Difference (Net)
-20.6
Standard Error of the Mean
5.84
2-Sided
90
-30.23
-10.93
Superiority
OG003
OG005
ANCOVA
0.0068
Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
Least Squares Mean Difference (Net)
-16.7
Standard Error of the Mean
6.71
2-Sided
90
-27.77
-5.61
Superiority
OG004
ANCOVA
0.2015
Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
Least Squares Mean Difference (Net)
-5.1
Standard Error of the Mean
6.03
2-Sided
90
-15.02
4.91
Superiority
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00058
OG00159
OG00252
OG00337
OG00443
OG00557
Title
Denominators
Categories
Title
Measurements
OG00012.1
OG0018.5
OG0027.7
OG0032.7
OG0042.3
OG0050
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00063
OG00165
OG00265
OG00347
OG00449
OG00566
Title
Denominators
Categories
Title
Measurements
OG0007.9
OG0014.6
OG0024.6
OG00310.6
OG0044.1
OG0059.1
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-2.4± 1.51
OG001-3.0± 1.50
OG002-2.6± 1.50
OG003
Week 8
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00263
ParticipantsOG00348
Week 12
ParticipantsOG00059
ParticipantsOG00162
ParticipantsOG00260
ParticipantsOG00344
Week 16
ParticipantsOG00056
ParticipantsOG00157
ParticipantsOG00255
ParticipantsOG00343
Week 20
ParticipantsOG00052
ParticipantsOG00159
ParticipantsOG00253
ParticipantsOG00343
Week 24
ParticipantsOG00052
ParticipantsOG00158
ParticipantsOG00252
ParticipantsOG00336
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG00345
OG00448
OG00557
Title
Denominators
Categories
Week 4
ParticipantsOG00061
ParticipantsOG00160
ParticipantsOG00255
ParticipantsOG00344
ParticipantsOG00447
ParticipantsOG00556
Title
Measurements
OG0000.1± 0.80
OG0010.4± 0.82
OG002-0.2± 0.84
OG003
Week 8
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00252
ParticipantsOG00343
Week 16
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00334
Week 24
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00241
ParticipantsOG00327
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-4.9± 2.63
OG0013.1± 2.61
OG002-5.0± 2.60
OG003
Week 8
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00263
ParticipantsOG00348
Week 12
ParticipantsOG00059
ParticipantsOG00162
ParticipantsOG00260
ParticipantsOG00344
Week 16
ParticipantsOG00056
ParticipantsOG00157
ParticipantsOG00256
ParticipantsOG00343
Week 20
ParticipantsOG00052
ParticipantsOG00159
ParticipantsOG00253
ParticipantsOG00343
Week 24
ParticipantsOG00052
ParticipantsOG00158
ParticipantsOG00252
ParticipantsOG00336
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG0002.7± 17.19
OG0011.1± 16.71
OG002-1.1± 16.74
OG003
Week 16
ParticipantsOG00054
ParticipantsOG00155
ParticipantsOG00256
ParticipantsOG00341
Week 24
ParticipantsOG00050
ParticipantsOG00156
ParticipantsOG00249
ParticipantsOG00332
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-0.3± 0.25
OG001-0.5± 0.25
OG002-0.6± 0.25
OG003
Week 8
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00263
ParticipantsOG00348
Week 12
ParticipantsOG00059
ParticipantsOG00162
ParticipantsOG00260
ParticipantsOG00344
Week 16
ParticipantsOG00056
ParticipantsOG00157
ParticipantsOG00255
ParticipantsOG00343
Week 20
ParticipantsOG00052
ParticipantsOG00159
ParticipantsOG00253
ParticipantsOG00343
Week 24
ParticipantsOG00052
ParticipantsOG00158
ParticipantsOG00252
ParticipantsOG00336
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0001.6
OG0011.5
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG00345
OG00448
OG00557
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00557
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
Week 16
ParticipantsOG00061
ParticipantsOG00158
ParticipantsOG00258
ParticipantsOG00339
Week 24
ParticipantsOG00058
ParticipantsOG00159
ParticipantsOG00252
ParticipantsOG00337
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG00345
OG00448
OG00557
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00557
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
Week 16
ParticipantsOG00061
ParticipantsOG00158
ParticipantsOG00258
ParticipantsOG00339
Week 24
ParticipantsOG00058
ParticipantsOG00159
ParticipantsOG00252
ParticipantsOG00337
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG00345
OG00448
OG00557
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00557
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
Week 16
ParticipantsOG00061
ParticipantsOG00158
ParticipantsOG00258
ParticipantsOG00339
Week 24
ParticipantsOG00058
ParticipantsOG00159
ParticipantsOG00252
ParticipantsOG00337
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00163
OG00259
OG00345
OG00448
OG00557
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
ParticipantsOG00448
ParticipantsOG00557
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00259
ParticipantsOG00345
Week 16
ParticipantsOG00061
ParticipantsOG00158
ParticipantsOG00258
ParticipantsOG00339
Week 24
ParticipantsOG00058
ParticipantsOG00159
ParticipantsOG00252
ParticipantsOG00337
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0003.1
OG0013.0
OG0021.5
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00566
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00350
Week 12
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00349
Week 16
ParticipantsOG00063
ParticipantsOG00162
ParticipantsOG00266
ParticipantsOG00347
Week 20
ParticipantsOG00061
ParticipantsOG00167
ParticipantsOG00264
ParticipantsOG00349
Week 24
ParticipantsOG00063
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00347
OG001
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-3.9± 1.34
OG001-2.9± 1.31
OG002-4.4± 1.31
OG003
Week 16
ParticipantsOG00054
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00341
Week 24
ParticipantsOG00050
ParticipantsOG00156
ParticipantsOG00250
ParticipantsOG00334
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-1.2± 0.71
OG001-1.1± 0.69
OG002-1.7± 0.69
OG003
Week 16
ParticipantsOG00054
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00341
Week 24
ParticipantsOG00050
ParticipantsOG00156
ParticipantsOG00250
ParticipantsOG00334
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-1.9± 0.56
OG001-1.6± 0.55
OG002-2.4± 0.55
OG003
Week 16
ParticipantsOG00054
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00341
Week 24
ParticipantsOG00050
ParticipantsOG00156
ParticipantsOG00250
ParticipantsOG00334
PF-06651600 100 mg - 50 mg QD
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00064
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Week 4
ParticipantsOG00062
ParticipantsOG00166
ParticipantsOG00264
ParticipantsOG00350
ParticipantsOG00447
ParticipantsOG00563
Title
Measurements
OG000-0.8± 0.37
OG001-0.3± 0.36
OG002-0.2± 0.36
OG003
Week 16
ParticipantsOG00054
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00341
Week 24
ParticipantsOG00050
ParticipantsOG00156
ParticipantsOG00250
ParticipantsOG00334
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00062
OG00164
OG00265
OG00346
OG00448
OG00565
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00065
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Participants With All-Causality TEAEs
Title
Measurements
OG00056
OG00145
OG00254
OG00330
OG00440
OG00552
Participants With Treatment-Related TEAEs
Title
Measurements
OG00032
OG00119
OG00220
OG003
Participants With All-Causality SAEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Participants With Treatment-Related SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06651600 50 mg QD
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00065
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Participants With Anaemia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants With Neutropenia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants With Thrombocytopenia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants With Lymphopenia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
OG003
PF-06651600 30 mg QD
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00065
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
OG004
PF-06651600 10 mg QD
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
OG005
Placebo
Participants were randomized to receive placebo for 24 weeks.
Units
Counts
Participants
OG00065
OG00167
OG00267
OG00350
OG00449
OG00566
Title
Denominators
Categories
Bilirubin > 1.5 x upper limit of normal (ULN)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
AST > 2.5 x ULN
Title
Measurements
OG0001
OG0010
OG0021
OG003
ALT > 2.5 x ULN
Title
Measurements
OG0000
OG0010
OG0021
OG003
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
OG002
EXT PF-06651600 200 mg - 50 mg QD
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
OG003
EXT PF-06651600 50 mg QD
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
OG004
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Units
Counts
Participants
OG00055
OG00143
OG002187
OG0036
OG0042
Title
Denominators
Categories
Participants With All-Causality TEAEs
Title
Measurements
OG00038
OG00132
OG002119
OG0033
OG0042
Participants With Treatment-Related TEAEs
Title
Measurements
OG00020
OG00112
OG00236
OG003
Participants With All-Causality SAEs
Title
Measurements
OG0001
OG0010
OG0021
OG003
Participants With Treatment-Related SAEs
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
EXT PF-06651600 200 mg - 50 mg QD
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
OG003
EX PF-06651600 50mg QD
50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.
OG004
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Units
Counts
Participants
OG00055
OG00143
OG002187
OG0036
OG0042
Title
Denominators
Categories
Participants With Anemia
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
Participants With Neutropenia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Participants With Thrombocytopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants With Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
EXT PF-06651600 200 mg - 50 mg QD
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
OG003
EXT PF-06651600 50 mg QD
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
OG004
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Units
Counts
Participants
OG00055
OG00143
OG002187
OG0036
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
EXT PF-06651600 200 mg - 50 mg QD
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
OG003
EXT PF-06651600 50 mg QD
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
OG004
EXT PF-06651600 30 mg QD
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.