A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03715829
• Collaborator: (none)
• Enrollment: 366
• Locations: 92
• Arms: 12
• Actual Duration (Months): 26.3
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Active Non-segmental Vitiligo	Drug: PF-06651600; Drug: PF-06651600; Drug: PF-06651600; Drug: PF-06651600; Drug: PF-06651600; Drug: placebo; Drug: PF06700841; Device: narrow-band UVB phototherapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 366 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Dose ranging period is a parallel design. Extension period is a sequential design.Dose ranging period is a parallel design. Extension period is a sequential design.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 26, 2018
• Actual Primary Completion Date: Feb 5, 2021
• Actual Study Completion Date: Feb 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks	Drug: PF-06651600; Induction dose 1. Oral tablet taken QD; Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 2 Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks	Drug: PF-06651600; Induction dose 2. Oral tablet taken QD; Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 3 Maintenance dose A given QD for 24 weeks	Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 4 Maintenance dose B given QD for 24 weeks	Drug: PF-06651600; Maintenance Dose B. Oral tablet taken QD
Experimental: Cohort 5 Maintenance dose C given QD for 24 weeks	Drug: PF-06651600; Maintenance Dose C. Oral tablet taken QD
Placebo Comparator: Cohort 6 Placebo given QD for 24 weeks	Drug: placebo; placebo
Experimental: Extension Cohort 1 4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks	Drug: PF06700841; Oral tablet taken QD
Experimental: Extension Cohort 2 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; Induction dose 1. Oral tablet taken QD; Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD; Device: narrow-band UVB phototherapy; Phototherapy will be combined with PF-06651600
Experimental: Extension Cohort 3 Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks	Drug: PF-06651600; Induction dose 1. Oral tablet taken QD; Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD
Experimental: Extension Cohort 4 Maintenance dose A given QD for 24 weeks	Drug: PF-06651600; Maintenance dose A. Oral tablet taken QD
Experimental: Extension Cohort 5 Maintenance dose B given QD for 24 weeks	Drug: PF-06651600; Maintenance Dose B. Oral tablet taken QD
No Intervention: Extension Cohort 6 Observation period for 24 weeks

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period [Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)]

   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.

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period [24 weeks]

   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.

3. Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period [Baseline up to Week 24]

   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).

4. Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period [Baseline up to Week 24]

   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).

5. Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period [24 weeks]

   Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.

6. Number of Participants With TEAEs and SAEs - Extension (Ext) Period [24 weeks]

   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.

7. Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period [24 weeks]

   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.

8. Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period [24 Weeks]

   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.

9. Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period [24 weeks]

   Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.

Secondary Outcome Measures

1. Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period [Week 24]

   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.

2. Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period [Week 24]

   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).

3. Percent Change From Baseline in T-VASI at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

   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).

4. Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 16 and 24]

   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.

5. Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

   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).

6. Percent Change From Baseline in SA-VES at Designated Time Points - DR Period [Baseline, Weeks 4, 16 and 24]

   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).

7. Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

   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).

8. Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

   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).

9. Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

   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).

10. Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

11. Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

12. Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 16 and 24]

    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.

13. Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 16 and 24]

    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.

14. Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 16 and 24]

    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.

15. Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 16 and 24]

    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.

16. Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

17. Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

18. Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

19. Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period [Baseline, Weeks 4, 8, 12, 16, 20 and 24]

    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).

20. Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period [Baseline, Weeks 4, 16 and 24]

    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).

21. Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period [Baseline, Weeks 4, 16 and 24]

    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).

22. Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period [Baseline, Weeks 4, 16 and 24]

    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).

23. Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period [Baseline, Weeks 4, 16 and 24]

    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).

24. Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period [Week 24]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marvel Research, LLC	Huntington Beach	California	United States	92647
2	University of California, Irvine, Dermatology Clinical Research Center	Irvine	California	United States	92697
3	Vitiligo and Pigmentation Institute Of Southern California	Los Angeles	California	United States	90036
4	Dermatology Specialist, Inc.	Murrieta	California	United States	92562
5	Dermatology Specialists, Inc.	Oceanside	California	United States	92056
6	UC Davis Health	Sacramento	California	United States	95816
7	Brookside Dermatology Associates	Bridgeport	Connecticut	United States	06606
8	New England Research Associates, LLC	Bridgeport	Connecticut	United States	06606
9	New Horizon Research Center	Miami	Florida	United States	33165
10	Park Avenue Dermatology	Orange Park	Florida	United States	32073
11	ForCare Clinical Research	Tampa	Florida	United States	33613
12	Advanced Skin and MOHS Surgery Center, c/o TrialSpark, Inc.	Chicago	Illinois	United States	60657
13	Chevy Chase Dermatology Center (TrialSpark, Inc.)	Chevy Chase	Maryland	United States	20815
14	TrialSpark - Samantha Toerge, MD	Chevy Chase	Maryland	United States	20815
15	TrialSpark - Ronald Shore, MD	Rockville	Maryland	United States	20852
16	Tobias & Battite, Inc.	Boston	Massachusetts	United States	02111
17	Tufts Medical Center	Boston	Massachusetts	United States	02111
18	UMass Memorial Medical Center, Hahnemann Campus	Worcester	Massachusetts	United States	01605
19	Investigational Drug Service Pharmacy	Worcester	Massachusetts	United States	01655
20	UMass Memorial Medical Center Ear Nose and Throat	Worcester	Massachusetts	United States	01655
21	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
22	Henry Ford Hospital Department of Dermatology	Detroit	Michigan	United States	48202
23	University of Minnesota Department of Dermatology	Minneapolis	Minnesota	United States	55455
24	The Dermatology Group, P.C.	Verona	New Jersey	United States	07044
25	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10003
26	Upper West Side Dermatology c/o TrialSpark, Inc	New York	New York	United States	10023
27	MDCS: Medical Dermatology & Cosmetic Surgery (TrialSpark, Inc.)	New York	New York	United States	10065
28	South Nassau Dermatology	Oceanside	New York	United States	11572
29	TrialSpark, Inc. - Russell W. Cohen, MD	Oceanside	New York	United States	11572
30	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28411
31	Remington-Davis, Inc. Clinical Research	Columbus	Ohio	United States	43215
32	ForeFront Dermatology	Columbus	Ohio	United States	43220
33	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma	United States	74136
34	University Physicians Group	Austin	Texas	United States	78701
35	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390-9191
36	Pickens Academic Tower	Houston	Texas	United States	77030
37	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
38	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
39	Virginia Clinical Research, Inc	Norfolk	Virginia	United States	23502
40	Tamjidi Skin Institute (TrialSpark, Inc.)	Vienna	Virginia	United States	22182
41	The Skin Hospital	Darlinghurst	New South Wales	Australia	2010
42	Premier Specialists Pty Ltd	Kogarah	New South Wales	Australia	2217
43	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland	Australia	4102
44	Skin Health Institute	Carlton	Victoria	Australia	3053
45	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
46	The Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
47	The Royal Melbourne Hospital	Parkville	Victoria	Australia	3052
48	Hôpital Erasme Dermatology	Brussels		Belgium	1070
49	UZ Brussel - Dermatology	Brussel		Belgium	1090
50	UZ Gent - Dermatology	Gent		Belgium	9000
51	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia	Canada	V3R 6A7
52	Enverus Medical Research	Surrey	British Columbia	Canada	V3V 0C6
53	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 4E8
54	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
55	CCA Medical Research	Ajax	Ontario	Canada	L1S 7K8
56	Guenther Research Inc.	London	Ontario	Canada	N6A 3H7
57	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X3
58	DermEdge Research	Mississauga	Ontario	Canada	L5H 1G9
59	North York Research Inc.	North York	Ontario	Canada	M2M 4J5
60	The Centre for Clinical Trials	Oakville	Ontario	Canada	L6J 7W5
61	The Centre for Dermatology	Richmond Hill	Ontario	Canada	L4B 1A5
62	K.Papp Clinical Research	Waterloo	Ontario	Canada	N2J 1C4
63	Innovaderm Research Inc.	Montreal	Quebec	Canada	H2X 2V1
64	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec	Canada	J1L 0H8
65	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec		Canada	G1V 4X7
66	Centre de Recherche Saint-Louis	Quebec		Canada	G1W 4R4
67	Centre de Recherche Saint-Louis	Quebec		Canada	G1W1S2
68	Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz	Bad Bentheim		Germany	48455
69	Universitaetsklinikum Erlangen Hautklinik Studienambulanz	Erlangen		Germany	91054
70	Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie	Frankfurt am Main		Germany	60590
71	Universitaetsklinikum Schleswig-Holstein, Campus Luebeck CCIM	Luebeck		Germany	23538
72	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz		Germany	55131
73	Universitaetsklinikum Muenster	Muenster		Germany	48149
74	Istituti Fisioterapici Ospitalieri, Istituto di Ricovero e Cura a Carattere Scientifico,	Roma	RM	Italy	00144
75	Nagoya City University Hospital - Dermatology	Nagoya	Aichi	Japan	467-8602
76	Tohoku University Hospital	Sendai	Miyagi	Japan	980-8574
77	Nippon Medical School Hospital	Bunkyo-ku	Tokyo	Japan	113-8603
78	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo	Japan	160-0023
79	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi	Japan	400-8506
80	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10326
81	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do	Korea, Republic of	16247
82	Ajou University Hospital	Suwon	Gyeonggi-do	Korea, Republic of	16499
83	Inha University Hospital	Incheon		Korea, Republic of	22332
84	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
85	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
86	Hospital Universitario Reina Sofia	Cordoba		Spain	14004
87	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
88	Hospital Universitario La Paz	Madrid		Spain	28046
89	Hospital Universitari i Politecnic La Fe	Valencia		Spain	46026
90	Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
91	National Cheng Kung University Hospital	Tainan		Taiwan	70403
92	National Taiwan University Hospital	Taipei		Taiwan	10002

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jun 26, 2020
• Statistical Analysis Plan - Feb 25, 2021

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03715829
• Other Study ID Numbers: B7981019; 2018-001271-20
• First Posted: Oct 23, 2018
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitiligo; PF-06700841

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo	Extension (EXT) PF-06700841 60 mg - 30 mg QD	EXT PF-06651600 200 Mg-50 mg QD + nbUVB	EXT PF-06651600 200 mg - 50 mg QD	EXT PF-06651600 50 mg QD	EXT PF-06651600 30 mg QD
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.	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.	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.	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.	Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Period Title: Dose Ranging Period
STARTED	65	67	67	50	49	66	0	0	0	0	0
COMPLETED	53	58	54	36	42	55	0	0	0	0	0
NOT COMPLETED	12	9	13	14	7	11	0	0	0	0	0
Period Title: Dose Ranging Period
STARTED	0	0	0	0	0	0	55	43	187	6	2
COMPLETED	0	0	0	0	0	0	47	27	158	3	2
NOT COMPLETED	0	0	0	0	0	0	8	16	29	3	0

Baseline Characteristics

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo	Total
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.	Total of all reporting groups
Overall Participants	65	67	67	50	49	66	364
Age, Customized (Count of Participants)
<18 Years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
18 - 44 Years	33 50.8%	29 43.3%	33 49.3%	20 40%	16 32.7%	30 45.5%	161 44.2%
45 - 64 Years	30 46.2%	37 55.2%	34 50.7%	30 60%	31 63.3%	32 48.5%	194 53.3%
≥65 Years	2 3.1%	1 1.5%	0 0%	0 0%	2 4.1%	4 6.1%	9 2.5%
Sex: Female, Male (Count of Participants)
Female	30 46.2%	31 46.3%	39 58.2%	28 56%	25 51%	40 60.6%	193 53%
Male	35 53.8%	36 53.7%	28 41.8%	22 44%	24 49%	26 39.4%	171 47%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 16.9%	9 13.4%	11 16.4%	12 24%	7 14.3%	7 10.6%	57 15.7%
Not Hispanic or Latino	54 83.1%	58 86.6%	54 80.6%	38 76%	41 83.7%	58 87.9%	303 83.2%
Unknown or Not Reported	0 0%	0 0%	2 3%	0 0%	1 2%	1 1.5%	4 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	1 0.3%
Asian	15 23.1%	17 25.4%	17 25.4%	5 10%	11 22.4%	21 31.8%	86 23.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 4.6%	0 0%	0 0%	4 8%	1 2%	2 3%	10 2.7%
White	44 67.7%	47 70.1%	45 67.2%	39 78%	33 67.3%	38 57.6%	246 67.6%
More than one race	0 0%	1 1.5%	1 1.5%	0 0%	2 4.1%	1 1.5%	5 1.4%
Unknown or Not Reported	3 4.6%	2 3%	4 6%	1 2%	2 4.1%	4 6.1%	16 4.4%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Description	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.
Time Frame	Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Least Squares Mean (Standard Error) [Percent Change]	-21.2 (4.13)	-21.2 (4.16)	-18.5 (4.44)	-14.6 (5.47)	-3.0 (4.65)	2.1 (4.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-06651600 200 mg - 50 mg QD, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference (Net)
	Estimated Value	-23.2
	Confidence Interval	(2-Sided) 90%; -32.53 to -13.96
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.62
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-06651600 100 mg - 50 mg QD, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference (Net)
	Estimated Value	-23.2
	Confidence Interval	(2-Sided) 90%; -32.53 to -13.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.63
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06651600 50 mg QD, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference (Net)
	Estimated Value	-20.6
	Confidence Interval	(2-Sided) 90%; -30.23 to -10.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.84
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-06651600 30 mg QD, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0068
	Comments	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference (Net)
	Estimated Value	-16.7
	Confidence Interval	(2-Sided) 90%; -27.77 to -5.61
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.71
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-06651600 10 mg QD
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2015
	Comments	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.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference (Net)
	Estimated Value	-5.1
	Confidence Interval	(2-Sided) 90%; -15.02 to 4.91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.03
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	58	59	52	37	43	57
Number [Percentage of Participants]	12.1 18.6%	8.5 12.7%	7.7 11.5%	2.7 5.4%	2.3 4.7%	0 0%

3. Secondary Outcome

Title	Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Description	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).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	63	65	65	47	49	66
Number [Percentage of Participants]	7.9 12.2%	4.6 6.9%	4.6 6.9%	10.6 21.2%	4.1 8.4%	9.1 13.8%

4. Secondary Outcome

Title	Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-2.4 (1.51)	-3.0 (1.50)	-2.6 (1.50)	-5.1 (1.72)	-2.9 (1.76)	-1.4 (1.52)
Week 8	-6.2 (2.03)	-5.4 (2.01)	-5.1 (2.01)	-6.6 (2.33)	-3.0 (2.32)	-5.8 (2.02)
Week 12	-7.2 (2.44)	-11.9 (2.40)	-9.1 (2.40)	-11.4 (2.82)	-4.9 (2.76)	-8.0 (2.40)
Week 16	-10.0 (2.66)	-13.1 (2.67)	-12.6 (2.66)	-11.9 (3.03)	-5.7 (3.03)	-12.0 (2.62)
Week 20	-13.8 (3.13)	-16.0 (2.98)	-14.2 (3.07)	-12.0 (3.43)	-9.2 (3.51)	-13.3 (3.04)
Week 24	-14.7 (3.49)	-19.2 (3.29)	-14.7 (3.44)	-14.0 (4.15)	-12.1 (3.88)	-11.0 (3.34)

5. Secondary Outcome

Title	Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
Description	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.
Time Frame	Baseline, Weeks 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Week 4	0.1 (0.80)	0.4 (0.82)	-0.2 (0.84)	-1.2 (0.94)	0.0 (0.91)	0.6 (0.83)
Week 8	-7.0 (1.42)	-5.3 (1.44)	-1.8 (1.46)	-1.4 (1.62)	-0.1 (1.55)	-0.2 (1.44)
Week 16	-17.0 (3.16)	-16.4 (3.25)	-10.7 (3.19)	-13.3 (3.87)	-5.6 (3.67)	-0.2 (3.27)
Week 24	-21.2 (4.13)	-21.2 (4.16)	-18.5 (4.44)	-14.6 (5.47)	-3.0 (4.65)	2.1 (4.06)

6. Secondary Outcome

Title	Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-4.9 (2.63)	3.1 (2.61)	-5.0 (2.60)	0.4 (2.96)	-5.3 (3.05)	-6.3 (2.63)
Week 8	-11.3 (5.35)	0.4 (5.32)	-8.8 (5.30)	10.1 (6.09)	-7.3 (6.12)	-7.5 (5.31)
Week 12	-15.9 (4.16)	-6.5 (4.11)	-12.2 (4.10)	-7.1 (4.77)	-9.8 (4.72)	-11.4 (4.08)
Week 16	-19.4 (4.85)	-6.2 (4.88)	-19.7 (4.82)	-6.4 (5.48)	-10.3 (5.46)	-13.3 (4.75)
Week 20	-21.9 (5.59)	-12.9 (5.35)	-23.2 (5.52)	0.0 (6.11)	-14.4 (6.30)	-15.3 (5.44)
Week 24	-28.3 (5.70)	-20.6 (5.38)	-26.2 (5.61)	-4.3 (6.70)	-13.9 (6.32)	-18.1 (5.43)

7. Secondary Outcome

Title	Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	2.7 (17.19)	1.1 (16.71)	-1.1 (16.74)	4.9 (19.25)	4.9 (19.84)	50.4 (17.13)
Week 16	4.7 (13.82)	-0.5 (13.48)	-3.7 (13.45)	6.9 (15.53)	-0.5 (15.87)	52.5 (13.72)
Week 24	0.0 (10.35)	-3.5 (10.02)	-4.3 (10.11)	-4.4 (11.89)	-1.6 (11.77)	44.0 (10.16)

8. Secondary Outcome

Title	Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-0.3 (0.25)	-0.5 (0.25)	-0.6 (0.25)	-1.0 (0.28)	-0.4 (0.29)	-0.2 (0.25)
Week 8	-0.9 (0.32)	-0.9 (0.32)	-0.9 (0.32)	-1.2 (0.37)	-0.5 (0.36)	-0.9 (0.32)
Week 12	-1.1 (0.41)	-2.0 (0.40)	-1.6 (0.40)	-1.8 (0.47)	-0.9 (0.46)	-1.6 (0.40)
Week 16	-1.5 (0.46)	-2.1 (0.46)	-1.9 (0.46)	-1.9 (0.53)	-0.9 (0.53)	-2.2 (0.46)
Week 20	-2.0 (0.55)	-2.8 (0.53)	-2.3 (0.54)	-2.0 (0.61)	-1.7 (0.62)	-2.2 (0.54)
Week 24	-2.3 (0.62)	-3.4 (0.59)	-2.4 (0.61)	-2.7 (0.74)	-2.0 (0.69)	-1.8 (0.60)

9. Secondary Outcome

Title	Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	1.6 2.5%	1.5 2.2%	0 0%	2.0 4%	0 0%	0 0%
Week 8	1.6 2.5%	1.5 2.2%	1.5 2.2%	4.0 8%	0 0%	1.5 2.3%
Week 12	1.6 2.5%	1.5 2.2%	1.5 2.2%	4.1 8.2%	0 0%	4.5 6.8%
Week 16	0 0%	3.2 4.8%	0 0%	2.1 4.2%	0 0%	6.3 9.5%
Week 20	4.9 7.5%	1.5 2.2%	1.6 2.4%	6.1 12.2%	2.1 4.3%	9.5 14.4%
Week 24	7.9 12.2%	4.6 6.9%	4.6 6.9%	10.6 21.2%	4.1 8.4%	9.1 13.8%

10. Secondary Outcome

Title	Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 20	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 20	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 20	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
Description	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.
Time Frame	Baseline, Weeks 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Week 4	0 0%	0 0%	0 0%	2.2 4.4%	0 0%	0 0%
Week 8	3.2 4.9%	0 0%	0 0%	2.2 4.4%	0 0%	0 0%
Week 16	14.8 22.8%	13.8 20.6%	6.9 10.3%	10.3 20.6%	2.4 4.9%	1.9 2.9%
Week 24	22.4 34.5%	25.4 37.9%	15.4 23%	18.9 37.8%	7.0 14.3%	1.8 2.7%

14. Secondary Outcome

Title	Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
Description	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.
Time Frame	Baseline, Weeks 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	1.6 2.5%	1.7 2.5%	5.2 7.8%	2.6 5.2%	2.4 4.9%	0 0%
Week 24	12.1 18.6%	8.5 12.7%	7.7 11.5%	2.7 5.4%	2.3 4.7%	0 0%

15. Secondary Outcome

Title	Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
Description	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.
Time Frame	Baseline, Weeks 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	1.7 2.5%	0 0%	0 0%	0 0%
Week 24	1.7 2.6%	0 0%	3.8 5.7%	0 0%	0 0%	0 0%

16. Secondary Outcome

Title	Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
Description	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.
Time Frame	Baseline, Weeks 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	63	59	45	48	57
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

17. Secondary Outcome

Title	Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	3.1 4.8%	3.0 4.5%	1.5 2.2%	2.0 4%	0 0%	3.0 4.5%
Week 8	9.4 14.5%	3.0 4.5%	4.5 6.7%	2.0 4%	4.1 8.4%	4.5 6.8%
Week 12	16.1 24.8%	9.1 13.6%	9.1 13.6%	8.2 16.4%	8.3 16.9%	9.1 13.8%
Week 16	14.3 22%	9.7 14.5%	13.6 20.3%	8.5 17%	10.6 21.6%	14.3 21.7%
Week 20	18.0 27.7%	14.9 22.2%	17.2 25.7%	12.2 24.4%	16.7 34.1%	17.5 26.5%
Week 24	20.6 31.7%	21.5 32.1%	15.4 23%	10.6 21.2%	18.4 37.6%	16.7 25.3%

18. Secondary Outcome

Title	Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	1.5 2.3%
Week 8	0 0%	0 0%	3.0 4.5%	2.0 4%	0 0%	0 0%
Week 12	1.6 2.5%	3.0 4.5%	4.5 6.7%	6.1 12.2%	2.1 4.3%	1.5 2.3%
Week 16	3.2 4.9%	0 0%	4.5 6.7%	4.3 8.6%	4.3 8.8%	7.9 12%
Week 20	6.6 10.2%	1.5 2.2%	9.4 14%	6.1 12.2%	6.3 12.9%	11.1 16.8%
Week 24	11.1 17.1%	4.6 6.9%	6.2 9.3%	4.3 8.6%	4.1 8.4%	13.6 20.6%

19. Secondary Outcome

Title	Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	1.5 2.2%	2.0 4%	0 0%	0 0%
Week 12	0 0%	0 0%	1.5 2.2%	2.0 4%	0 0%	0 0%
Week 16	1.6 2.5%	0 0%	3.0 4.5%	2.1 4.2%	2.1 4.3%	0 0%
Week 20	1.6 2.5%	1.5 2.2%	4.7 7%	2.0 4%	2.1 4.3%	1.6 2.4%
Week 24	1.6 2.5%	1.5 2.2%	3.1 4.6%	0 0%	4.1 8.4%	1.5 2.3%

20. Secondary Outcome

Title	Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8	0 0%	0 0%	0 0%	2.0 4%	0 0%	0 0%
Week 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Week 20	0 0%	0 0%	1.6 2.4%	0 0%	0 0%	0 0%
Week 24	0 0%	0 0%	1.5 2.2%	0 0%	0 0%	0 0%

21. Secondary Outcome

Title	Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-3.9 (1.34)	-2.9 (1.31)	-4.4 (1.31)	-4.4 (1.50)	-3.5 (1.54)	-5.1 (1.33)
Week 16	-6.5 (1.83)	-4.9 (1.79)	-6.3 (1.82)	-4.8 (2.07)	-10.5 (2.06)	-7.1 (1.78)
Week 24	-6.5 (1.99)	-3.6 (1.92)	-7.7 (1.99)	-7.0 (2.30)	-9.7 (2.22)	-6.4 (1.92)

22. Secondary Outcome

Title	Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-1.2 (0.71)	-1.1 (0.69)	-1.7 (0.69)	-1.8 (0.79)	-1.0 (0.81)	-2.5 (0.70)
Week 16	-2.1 (0.88)	-1.9 (0.86)	-2.6 (0.87)	-2.3 (1.00)	-4.1 (0.99)	-3.1 (0.85)
Week 24	-1.4 (0.98)	-1.7 (0.94)	-3.2 (0.97)	-2.8 (1.14)	-3.9 (1.09)	-2.2 (0.94)

23. Secondary Outcome

Title	Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-1.9 (0.56)	-1.6 (0.55)	-2.4 (0.55)	-1.7 (0.62)	-1.7 (0.64)	-1.8 (0.56)
Week 16	-3.4 (0.71)	-2.3 (0.70)	-3.2 (0.71)	-1.7 (0.80)	-4.3 (0.80)	-2.9 (0.69)
Week 24	-3.8 (0.76)	-2.1 (0.73)	-3.7 (0.76)	-3.1 (0.88)	-4.5 (0.84)	-3.2 (0.73)

24. Secondary Outcome

Title	Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
Description	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).
Time Frame	Baseline, Weeks 4, 16 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	64	67	67	50	49	66
Week 4	-0.8 (0.37)	-0.3 (0.36)	-0.2 (0.36)	-0.9 (0.41)	-0.7 (0.42)	-0.7 (0.37)
Week 16	-1.1 (0.50)	-0.8 (0.49)	-0.5 (0.50)	-0.9 (0.57)	-2.1 (0.56)	-1.0 (0.49)
Week 24	-1.4 (0.53)	0 (0.52)	-0.7 (0.53)	-1.3 (0.62)	-1.3 (0.60)	-0.9 (0.51)

25. Secondary Outcome

Title	Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	62	64	65	46	48	65
Number [Percentage of Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

26. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	65	67	67	50	49	66
Participants With All-Causality TEAEs	56 86.2%	45 67.2%	54 80.6%	30 60%	40 81.6%	52 78.8%
Participants With Treatment-Related TEAEs	32 49.2%	19 28.4%	20 29.9%	17 34%	18 36.7%	20 30.3%
Participants With All-Causality SAEs	0 0%	0 0%	1 1.5%	1 2%	1 2%	1 1.5%
Participants With Treatment-Related SAEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

27. Primary Outcome

Title	Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
Description	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).
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	PF-06651600 200mg - 50mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	65	67	67	50	49	66
Participants With Anaemia	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Participants With Neutropenia	0 0%	1 1.5%	0 0%	0 0%	1 2%	1 1.5%
Participants With Thrombocytopenia	1 1.5%	0 0%	0 0%	0 0%	0 0%	0 0%
Participants With Lymphopenia	1 1.5%	0 0%	0 0%	0 0%	0 0%	0 0%

28. Primary Outcome

Title	Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Description	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).
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	65	67	67	50	49	66
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

29. Primary Outcome

Title	Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Description	Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	PF-06651600 200 mg - 50 mg QD	PF-06651600 100 mg - 50 mg QD	PF-06651600 50 mg QD	PF-06651600 30 mg QD	PF-06651600 10 mg QD	Placebo
Arm/Group Description	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.	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.	Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Participants were randomized to receive placebo for 24 weeks.
Measure Participants	65	67	67	50	49	66
Bilirubin > 1.5 x upper limit of normal (ULN)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST > 2.5 x ULN	1 1.5%	0 0%	1 1.5%	0 0%	1 2%	0 0%
ALT > 2.5 x ULN	0 0%	0 0%	1 1.5%	1 2%	1 2%	1 1.5%

30. Primary Outcome

Title	Number of Participants With TEAEs and SAEs - Extension (Ext) Period
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	Extension (EXT) PF-06700841 60 mg - 30 mg QD	EXT PF-06651600 200 Mg-50 mg QD + nbUVB	EXT PF-06651600 200 mg - 50 mg QD	EXT PF-06651600 50 mg QD	EXT PF-06651600 30 mg QD
Arm/Group Description	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.	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.	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.	Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Measure Participants	55	43	187	6	2
Participants With All-Causality TEAEs	38 58.5%	32 47.8%	119 177.6%	3 6%	2 4.1%
Participants With Treatment-Related TEAEs	20 30.8%	12 17.9%	36 53.7%	0 0%	0 0%
Participants With All-Causality SAEs	1 1.5%	0 0%	1 1.5%	0 0%	0 0%
Participants With Treatment-Related SAEs	1 1.5%	0 0%	0 0%	0 0%	0 0%

31. Primary Outcome

Title	Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	Extension (EXT) PF-06700841 60 mg - 30 mg QD	EXT PF-06651600 200 Mg-50 mg QD + nbUVB	EXT PF-06651600 200 mg - 50 mg QD	EX PF-06651600 50mg QD	EXT PF-06651600 30 mg QD
Arm/Group Description	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.	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.	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.	50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.	Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Measure Participants	55	43	187	6	2
Participants With Anemia	0 0%	0 0%	0 0%	1 2%	0 0%
Participants With Neutropenia	1 1.5%	0 0%	1 1.5%	0 0%	0 0%
Participants With Thrombocytopenia	0 0%	0 0%	0 0%	0 0%	0 0%
Participants With Lymphopenia	0 0%	0 0%	0 0%	0 0%	0 0%

32. Primary Outcome

Title	Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Description	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.
Time Frame	24 Weeks

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received at least 1 dose of investigational product.

Arm/Group Title	Extension (EXT) PF-06700841 60 mg - 30 mg QD	EXT PF-06651600 200 Mg-50 mg QD + nbUVB	EXT PF-06651600 200 mg - 50 mg QD	EXT PF-06651600 50 mg QD	EXT PF-06651600 30 mg QD
Arm/Group Description	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.	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.	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.	Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Measure Participants	55	43	187	6	2
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%

33. Primary Outcome

Title	Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Description	Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Extension (EXT) PF-06700841 60 mg - 30 mg QD	EXT PF-06651600 200 Mg-50 mg QD + nbUVB	EXT PF-06651600 200 mg - 50 mg QD	EXT PF-06651600 50 mg QD	EXT PF-06651600 30 mg QD
Arm/Group Description	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.	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.	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.	Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Measure Participants	55	42	186	6	2
Bilirubin > 1.5 x ULN	0 0%	0 0%	0 0%	0 0%	0 0%
AST > 2.5 x ULN	0 0%	0 0%	0 0%	0 0%	0 0%
ALT > 2.5 x ULN	0 0%	0 0%	1 1.5%	0 0%	0 0%

Adverse Events

Time Frame	48 weeks
Adverse Event Reporting 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.
Arm/Group Title	PF-06651600 200 mg - 50 mg QD		PF-06651600 100 mg - 50 mg QD		PF-06651600 50 mg QD		PF-06651600 30 mg QD		PF-06651600 10 mg QD		Placebo		Extension (EXT) PF-06700841 60 mg - 30 mg QD		EX PF-06651600 200 mg - 50 mg QD + nbUVB		EX PF-06651600 200mg-50mg QD		EX PF-06651600 50mg QD		EXT PF-06651600 30 mg QD
Arm/Group Description	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.		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.		Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.		Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.		Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.		Participants were randomized to receive placebo for 24 weeks.		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.		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.		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.		50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.		Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
All Cause Mortality
	PF-06651600 200 mg - 50 mg QD		PF-06651600 100 mg - 50 mg QD		PF-06651600 50 mg QD		PF-06651600 30 mg QD		PF-06651600 10 mg QD		Placebo		Extension (EXT) PF-06700841 60 mg - 30 mg QD		EX PF-06651600 200 mg - 50 mg QD + nbUVB		EX PF-06651600 200mg-50mg QD		EX PF-06651600 50mg QD		EXT PF-06651600 30 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/67 (0%)		0/67 (0%)		0/50 (0%)		0/49 (0%)		0/66 (0%)		0/55 (0%)		0/43 (0%)		0/187 (0%)		0/6 (0%)		0/2 (0%)
Serious Adverse Events
	PF-06651600 200 mg - 50 mg QD		PF-06651600 100 mg - 50 mg QD		PF-06651600 50 mg QD		PF-06651600 30 mg QD		PF-06651600 10 mg QD		Placebo		Extension (EXT) PF-06700841 60 mg - 30 mg QD		EX PF-06651600 200 mg - 50 mg QD + nbUVB		EX PF-06651600 200mg-50mg QD		EX PF-06651600 50mg QD		EXT PF-06651600 30 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/67 (0%)		1/67 (1.5%)		1/50 (2%)		1/49 (2%)		1/66 (1.5%)		1/55 (1.8%)		0/43 (0%)		1/187 (0.5%)		0/6 (0%)		0/2 (0%)
Gastrointestinal disorders
Oesophageal spasm	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	1/50 (2%)	1	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Infections and infestations
Disseminated varicella zoster virus infection	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	1/55 (1.8%)	1	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	1/187 (0.5%)	1	0/6 (0%)	0	0/2 (0%)	0
Nervous system disorders
Migraine	0/65 (0%)	0	0/67 (0%)	0	1/67 (1.5%)	1	0/50 (0%)	0	1/49 (2%)	1	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Neurogenic bladder	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	1/66 (1.5%)	1	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	PF-06651600 200 mg - 50 mg QD		PF-06651600 100 mg - 50 mg QD		PF-06651600 50 mg QD		PF-06651600 30 mg QD		PF-06651600 10 mg QD		Placebo		Extension (EXT) PF-06700841 60 mg - 30 mg QD		EX PF-06651600 200 mg - 50 mg QD + nbUVB		EX PF-06651600 200mg-50mg QD		EX PF-06651600 50mg QD		EXT PF-06651600 30 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/65 (47.7%)		35/67 (52.2%)		32/67 (47.8%)		23/50 (46%)		22/49 (44.9%)		37/66 (56.1%)		17/55 (30.9%)		14/43 (32.6%)		46/187 (24.6%)		3/6 (50%)		2/2 (100%)
Blood and lymphatic system disorders
Anaemia	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Ear and labyrinth disorders
Ear pain	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/65 (0%)	0	1/67 (1.5%)	1	2/67 (3%)	3	0/50 (0%)	0	1/49 (2%)	1	4/66 (6.1%)	4	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Diarrhoea	0/65 (0%)	0	5/67 (7.5%)	7	2/67 (3%)	2	4/50 (8%)	5	1/49 (2%)	1	1/66 (1.5%)	2	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Dyspepsia	1/65 (1.5%)	1	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	3/49 (6.1%)	4	3/66 (4.5%)	3	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
General disorders
Fatigue	6/65 (9.2%)	6	1/67 (1.5%)	1	2/67 (3%)	2	0/50 (0%)	0	1/49 (2%)	1	1/66 (1.5%)	1	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Influenza like illness	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Infections and infestations
Bronchitis	0/65 (0%)	0	1/67 (1.5%)	1	1/67 (1.5%)	1	3/50 (6%)	6	0/49 (0%)	0	0/66 (0%)	0	1/55 (1.8%)	1	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	1/2 (50%)	1
Folliculitis	0/65 (0%)	0	1/67 (1.5%)	2	1/67 (1.5%)	1	1/50 (2%)	1	0/49 (0%)	0	4/66 (6.1%)	4	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastroenteritis	2/65 (3.1%)	2	0/67 (0%)	0	1/67 (1.5%)	1	3/50 (6%)	3	1/49 (2%)	1	1/66 (1.5%)	1	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Nasopharyngitis	8/65 (12.3%)	9	10/67 (14.9%)	11	16/67 (23.9%)	20	5/50 (10%)	8	5/49 (10.2%)	5	14/66 (21.2%)	20	3/55 (5.5%)	3	0/43 (0%)	0	8/187 (4.3%)	10	0/6 (0%)	0	0/2 (0%)	0
Upper respiratory tract infection	5/65 (7.7%)	6	10/67 (14.9%)	11	5/67 (7.5%)	8	8/50 (16%)	8	6/49 (12.2%)	7	8/66 (12.1%)	8	4/55 (7.3%)	4	2/43 (4.7%)	2	9/187 (4.8%)	10	0/6 (0%)	0	0/2 (0%)	0
Urinary tract infection	4/65 (6.2%)	5	4/67 (6%)	6	2/67 (3%)	2	2/50 (4%)	2	3/49 (6.1%)	3	3/66 (4.5%)	3	1/55 (1.8%)	2	3/43 (7%)	4	12/187 (6.4%)	16	1/6 (16.7%)	1	1/2 (50%)	1
COVID-19	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	2/187 (1.1%)	2	0/6 (0%)	0	1/2 (50%)	1
Influenza	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	3/55 (5.5%)	3	0/43 (0%)	0	2/187 (1.1%)	2	0/6 (0%)	0	0/2 (0%)	0
Onychomycosis	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	1/2 (50%)	1
Investigations
Blood creatine phosphokinase increased	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	3/55 (5.5%)	3	4/43 (9.3%)	5	3/187 (1.6%)	3	0/6 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	3/65 (4.6%)	3	3/67 (4.5%)	3	6/67 (9%)	8	0/50 (0%)	0	1/49 (2%)	1	3/66 (4.5%)	3	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Spinal segmental dysfunction	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Nervous system disorders
Headache	4/65 (6.2%)	4	7/67 (10.4%)	9	8/67 (11.9%)	8	1/50 (2%)	2	4/49 (8.2%)	5	8/66 (12.1%)	10	4/55 (7.3%)	4	3/43 (7%)	3	8/187 (4.3%)	8	0/6 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Insomnia	1/65 (1.5%)	1	0/67 (0%)	0	1/67 (1.5%)	1	3/50 (6%)	3	0/49 (0%)	0	1/66 (1.5%)	1	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	3/55 (5.5%)	3	2/43 (4.7%)	2	3/187 (1.6%)	3	0/6 (0%)	0	0/2 (0%)	0
Epistaxis	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Acne	4/65 (6.2%)	4	1/67 (1.5%)	1	4/67 (6%)	4	1/50 (2%)	1	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Dry skin	1/65 (1.5%)	1	4/67 (6%)	4	0/67 (0%)	0	2/50 (4%)	2	1/49 (2%)	1	2/66 (3%)	2	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pruritus	3/65 (4.6%)	3	2/67 (3%)	2	2/67 (3%)	2	1/50 (2%)	1	2/49 (4.1%)	2	5/66 (7.6%)	5	0/55 (0%)	0	3/43 (7%)	3	5/187 (2.7%)	6	0/6 (0%)	0	0/2 (0%)	0
Urticaria	2/65 (3.1%)	3	3/67 (4.5%)	6	1/67 (1.5%)	1	0/50 (0%)	0	3/49 (6.1%)	4	0/66 (0%)	0	0/55 (0%)	0	0/43 (0%)	0	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Photosensitivity reaction	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	3/43 (7%)	4	0/187 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Rash	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	0/55 (0%)	0	1/43 (2.3%)	1	1/187 (0.5%)	3	0/6 (0%)	0	1/2 (50%)	1
Vascular disorders
Hypertension	0/65 (0%)	0	0/67 (0%)	0	0/67 (0%)	0	0/50 (0%)	0	0/49 (0%)	0	0/66 (0%)	0	1/55 (1.8%)	1	0/43 (0%)	0	2/187 (1.1%)	2	1/6 (16.7%)	1	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

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

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