Trial Outcomes & Findings for A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects (NCT NCT03715829)

NCT ID: NCT03715829

Last Updated: 2022-03-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 366 participants
• Primary outcome timeframe: Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
• Results posted on: 2022-03-25

Participant Flow

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.

Participant milestones

Measure	PF-06651600 200 mg - 50 mg QD Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.	PF-06651600 100 mg - 50 mg QD Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.	PF-06651600 50 mg QD Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.	Extension (EXT) PF-06700841 60 mg - 30 mg QD After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.	EXT PF-06651600 200 Mg-50 mg QD + nbUVB Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had \<10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.	EXT PF-06651600 200 mg - 50 mg QD Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.	EXT PF-06651600 50 mg QD Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	EXT PF-06651600 30 mg QD Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Dose Ranging Period STARTED	65	67	67	50	49	66	0	0	0	0	0
Dose Ranging Period COMPLETED	53	58	54	36	42	55	0	0	0	0	0
Dose Ranging Period NOT COMPLETED	12	9	13	14	7	11	0	0	0	0	0
Extension Period STARTED	0	0	0	0	0	0	55	43	187	6	2
Extension Period COMPLETED	0	0	0	0	0	0	47	27	158	3	2
Extension Period NOT COMPLETED	0	0	0	0	0	0	8	16	29	3	0

Reasons for withdrawal

Measure	PF-06651600 200 mg - 50 mg QD Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.	PF-06651600 100 mg - 50 mg QD Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.	PF-06651600 50 mg QD Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.	Extension (EXT) PF-06700841 60 mg - 30 mg QD After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.	EXT PF-06651600 200 Mg-50 mg QD + nbUVB Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had \<10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.	EXT PF-06651600 200 mg - 50 mg QD Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.	EXT PF-06651600 50 mg QD Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.	EXT PF-06651600 30 mg QD Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Dose Ranging Period Adverse Event	2	4	5	2	3	3	0	0	0	0	0
Dose Ranging Period Lack of Efficacy	0	1	0	1	0	0	0	0	0	0	0
Dose Ranging Period Lost to Follow-up	2	0	1	1	1	2	0	0	0	0	0
Dose Ranging Period Protocol Violation	0	0	0	1	0	0	0	0	0	0	0
Dose Ranging Period Withdrawal by Subject	8	4	3	9	2	3	0	0	0	0	0
Dose Ranging Period Medication Error Without Associated Adverse Event	0	0	1	0	0	0	0	0	0	0	0
Dose Ranging Period No Longer Meets Eligibility Criteria	0	0	1	0	1	0	0	0	0	0	0
Dose Ranging Period Other	0	0	2	0	0	3	0	0	0	0	0
Extension Period Adverse Event	0	0	0	0	0	0	3	1	6	0	0
Extension Period Lack of Efficacy	0	0	0	0	0	0	1	9	2	0	0
Extension Period Lost to Follow-up	0	0	0	0	0	0	0	0	2	0	0
Extension Period Protocol Violation	0	0	0	0	0	0	0	0	1	0	0
Extension Period Withdrawal by Subject	0	0	0	0	0	0	3	3	12	3	0
Extension Period Medication Error Without Associated Adverse Event	0	0	0	0	0	0	0	1	1	0	0
Extension Period No Longer Meets Eligibility Criteria	0	0	0	0	0	0	0	0	1	0	0
Extension Period Other	0	0	0	0	0	0	1	2	4	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PF-06651600 200 mg - 50 mg QD n=65 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.	Total n=364 Participants Total of all reporting groups
Age, Customized <18 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Customized 18 - 44 Years	33 Participants n=5 Participants	29 Participants n=7 Participants	33 Participants n=5 Participants	20 Participants n=4 Participants	16 Participants n=21 Participants	30 Participants n=10 Participants	161 Participants n=115 Participants
Age, Customized 45 - 64 Years	30 Participants n=5 Participants	37 Participants n=7 Participants	34 Participants n=5 Participants	30 Participants n=4 Participants	31 Participants n=21 Participants	32 Participants n=10 Participants	194 Participants n=115 Participants
Age, Customized ≥65 Years	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	9 Participants n=115 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	31 Participants n=7 Participants	39 Participants n=5 Participants	28 Participants n=4 Participants	25 Participants n=21 Participants	40 Participants n=10 Participants	193 Participants n=115 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	36 Participants n=7 Participants	28 Participants n=5 Participants	22 Participants n=4 Participants	24 Participants n=21 Participants	26 Participants n=10 Participants	171 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=10 Participants	57 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	58 Participants n=7 Participants	54 Participants n=5 Participants	38 Participants n=4 Participants	41 Participants n=21 Participants	58 Participants n=10 Participants	303 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants	21 Participants n=10 Participants	86 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	10 Participants n=115 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	47 Participants n=7 Participants	45 Participants n=5 Participants	39 Participants n=4 Participants	33 Participants n=21 Participants	38 Participants n=10 Participants	246 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	16 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period	-21.2 Percent Change Standard Error 4.13	-21.2 Percent Change Standard Error 4.16	-18.5 Percent Change Standard Error 4.44	-14.6 Percent Change Standard Error 5.47	-3.0 Percent Change Standard Error 4.65	2.1 Percent Change Standard Error 4.06

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=65 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period Participants With All-Causality TEAEs	56 Participants	45 Participants	54 Participants	30 Participants	40 Participants	52 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period Participants With Treatment-Related TEAEs	32 Participants	19 Participants	20 Participants	17 Participants	18 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period Participants With All-Causality SAEs	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period Participants With Treatment-Related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

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

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=65 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period Participants With Anaemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period Participants With Neutropenia	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period Participants With Thrombocytopenia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period Participants With Lymphopenia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

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

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=65 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=65 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period Bilirubin > 1.5 x upper limit of normal (ULN)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period AST > 2.5 x ULN	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period ALT > 2.5 x ULN	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=55 Participants 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.	PF-06651600 100 mg - 50 mg QD n=43 Participants 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.	PF-06651600 50 mg QD n=187 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=6 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=2 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.
Number of Participants With TEAEs and SAEs - Extension (Ext) Period Participants With All-Causality TEAEs	38 Participants	32 Participants	119 Participants	3 Participants	2 Participants	—
Number of Participants With TEAEs and SAEs - Extension (Ext) Period Participants With Treatment-Related TEAEs	20 Participants	12 Participants	36 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs and SAEs - Extension (Ext) Period Participants With All-Causality SAEs	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs and SAEs - Extension (Ext) Period Participants With Treatment-Related SAEs	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=55 Participants 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.	PF-06651600 100 mg - 50 mg QD n=43 Participants 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.	PF-06651600 50 mg QD n=187 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=6 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=2 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period Participants With Anemia	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period Participants With Neutropenia	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period Participants With Thrombocytopenia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period Participants With Lymphopenia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 24 Weeks

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

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=55 Participants 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.	PF-06651600 100 mg - 50 mg QD n=43 Participants 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.	PF-06651600 50 mg QD n=187 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=6 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=2 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 24 weeks

Population: 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.

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

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=55 Participants 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.	PF-06651600 100 mg - 50 mg QD n=42 Participants 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.	PF-06651600 50 mg QD n=186 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=6 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=2 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo Participants were randomized to receive placebo for 24 weeks.
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period Bilirubin > 1.5 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period AST > 2.5 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period ALT > 2.5 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=58 Participants 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.	PF-06651600 100 mg - 50 mg QD n=59 Participants 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.	PF-06651600 50 mg QD n=52 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=37 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=43 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period	12.1 Percentage of Participants	8.5 Percentage of Participants	7.7 Percentage of Participants	2.7 Percentage of Participants	2.3 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=63 Participants 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.	PF-06651600 100 mg - 50 mg QD n=65 Participants 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.	PF-06651600 50 mg QD n=65 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=47 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period	7.9 Percentage of Participants	4.6 Percentage of Participants	4.6 Percentage of Participants	10.6 Percentage of Participants	4.1 Percentage of Participants	9.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 16	-10.0 Percent Change Standard Error 2.66	-13.1 Percent Change Standard Error 2.67	-12.6 Percent Change Standard Error 2.66	-11.9 Percent Change Standard Error 3.03	-5.7 Percent Change Standard Error 3.03	-12.0 Percent Change Standard Error 2.62
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 20	-13.8 Percent Change Standard Error 3.13	-16.0 Percent Change Standard Error 2.98	-14.2 Percent Change Standard Error 3.07	-12.0 Percent Change Standard Error 3.43	-9.2 Percent Change Standard Error 3.51	-13.3 Percent Change Standard Error 3.04
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 24	-14.7 Percent Change Standard Error 3.49	-19.2 Percent Change Standard Error 3.29	-14.7 Percent Change Standard Error 3.44	-14.0 Percent Change Standard Error 4.15	-12.1 Percent Change Standard Error 3.88	-11.0 Percent Change Standard Error 3.34
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 4	-2.4 Percent Change Standard Error 1.51	-3.0 Percent Change Standard Error 1.50	-2.6 Percent Change Standard Error 1.50	-5.1 Percent Change Standard Error 1.72	-2.9 Percent Change Standard Error 1.76	-1.4 Percent Change Standard Error 1.52
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 8	-6.2 Percent Change Standard Error 2.03	-5.4 Percent Change Standard Error 2.01	-5.1 Percent Change Standard Error 2.01	-6.6 Percent Change Standard Error 2.33	-3.0 Percent Change Standard Error 2.32	-5.8 Percent Change Standard Error 2.02
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period Week 12	-7.2 Percent Change Standard Error 2.44	-11.9 Percent Change Standard Error 2.40	-9.1 Percent Change Standard Error 2.40	-11.4 Percent Change Standard Error 2.82	-4.9 Percent Change Standard Error 2.76	-8.0 Percent Change Standard Error 2.40

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16 and 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period Week 4	0.1 Percent Change Standard Error 0.80	0.4 Percent Change Standard Error 0.82	-0.2 Percent Change Standard Error 0.84	-1.2 Percent Change Standard Error 0.94	0.0 Percent Change Standard Error 0.91	0.6 Percent Change Standard Error 0.83
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period Week 8	-7.0 Percent Change Standard Error 1.42	-5.3 Percent Change Standard Error 1.44	-1.8 Percent Change Standard Error 1.46	-1.4 Percent Change Standard Error 1.62	-0.1 Percent Change Standard Error 1.55	-0.2 Percent Change Standard Error 1.44
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period Week 16	-17.0 Percent Change Standard Error 3.16	-16.4 Percent Change Standard Error 3.25	-10.7 Percent Change Standard Error 3.19	-13.3 Percent Change Standard Error 3.87	-5.6 Percent Change Standard Error 3.67	-0.2 Percent Change Standard Error 3.27
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period Week 24	-21.2 Percent Change Standard Error 4.13	-21.2 Percent Change Standard Error 4.16	-18.5 Percent Change Standard Error 4.44	-14.6 Percent Change Standard Error 5.47	-3.0 Percent Change Standard Error 4.65	2.1 Percent Change Standard Error 4.06

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 16 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period Week 4	2.7 Percent Change Standard Error 17.19	1.1 Percent Change Standard Error 16.71	-1.1 Percent Change Standard Error 16.74	4.9 Percent Change Standard Error 19.25	4.9 Percent Change Standard Error 19.84	50.4 Percent Change Standard Error 17.13
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period Week 16	4.7 Percent Change Standard Error 13.82	-0.5 Percent Change Standard Error 13.48	-3.7 Percent Change Standard Error 13.45	6.9 Percent Change Standard Error 15.53	-0.5 Percent Change Standard Error 15.87	52.5 Percent Change Standard Error 13.72
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period Week 24	0.0 Percent Change Standard Error 10.35	-3.5 Percent Change Standard Error 10.02	-4.3 Percent Change Standard Error 10.11	-4.4 Percent Change Standard Error 11.89	-1.6 Percent Change Standard Error 11.77	44.0 Percent Change Standard Error 10.16

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 4	-0.3 Units on a Scale Standard Error 0.25	-0.5 Units on a Scale Standard Error 0.25	-0.6 Units on a Scale Standard Error 0.25	-1.0 Units on a Scale Standard Error 0.28	-0.4 Units on a Scale Standard Error 0.29	-0.2 Units on a Scale Standard Error 0.25
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 8	-0.9 Units on a Scale Standard Error 0.32	-0.9 Units on a Scale Standard Error 0.32	-0.9 Units on a Scale Standard Error 0.32	-1.2 Units on a Scale Standard Error 0.37	-0.5 Units on a Scale Standard Error 0.36	-0.9 Units on a Scale Standard Error 0.32
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 12	-1.1 Units on a Scale Standard Error 0.41	-2.0 Units on a Scale Standard Error 0.40	-1.6 Units on a Scale Standard Error 0.40	-1.8 Units on a Scale Standard Error 0.47	-0.9 Units on a Scale Standard Error 0.46	-1.6 Units on a Scale Standard Error 0.40
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 16	-1.5 Units on a Scale Standard Error 0.46	-2.1 Units on a Scale Standard Error 0.46	-1.9 Units on a Scale Standard Error 0.46	-1.9 Units on a Scale Standard Error 0.53	-0.9 Units on a Scale Standard Error 0.53	-2.2 Units on a Scale Standard Error 0.46
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 20	-2.0 Units on a Scale Standard Error 0.55	-2.8 Units on a Scale Standard Error 0.53	-2.3 Units on a Scale Standard Error 0.54	-2.0 Units on a Scale Standard Error 0.61	-1.7 Units on a Scale Standard Error 0.62	-2.2 Units on a Scale Standard Error 0.54
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period Week 24	-2.3 Units on a Scale Standard Error 0.62	-3.4 Units on a Scale Standard Error 0.59	-2.4 Units on a Scale Standard Error 0.61	-2.7 Units on a Scale Standard Error 0.74	-2.0 Units on a Scale Standard Error 0.69	-1.8 Units on a Scale Standard Error 0.60

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 4	1.6 Percentage of Participants	1.5 Percentage of Participants	0 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 8	1.6 Percentage of Participants	1.5 Percentage of Participants	1.5 Percentage of Participants	4.0 Percentage of Participants	0 Percentage of Participants	1.5 Percentage of Participants
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 12	1.6 Percentage of Participants	1.5 Percentage of Participants	1.5 Percentage of Participants	4.1 Percentage of Participants	0 Percentage of Participants	4.5 Percentage of Participants
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	3.2 Percentage of Participants	0 Percentage of Participants	2.1 Percentage of Participants	0 Percentage of Participants	6.3 Percentage of Participants
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 20	4.9 Percentage of Participants	1.5 Percentage of Participants	1.6 Percentage of Participants	6.1 Percentage of Participants	2.1 Percentage of Participants	9.5 Percentage of Participants
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period Week 24	7.9 Percentage of Participants	4.6 Percentage of Participants	4.6 Percentage of Participants	10.6 Percentage of Participants	4.1 Percentage of Participants	9.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 12	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 20	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period Week 24	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 12	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 20	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period Week 24	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 12	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 20	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period Week 24	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16 and 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period Week 8	3.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period Week 16	14.8 Percentage of Participants	13.8 Percentage of Participants	6.9 Percentage of Participants	10.3 Percentage of Participants	2.4 Percentage of Participants	1.9 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period Week 24	22.4 Percentage of Participants	25.4 Percentage of Participants	15.4 Percentage of Participants	18.9 Percentage of Participants	7.0 Percentage of Participants	1.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16 and 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period Week 16	1.6 Percentage of Participants	1.7 Percentage of Participants	5.2 Percentage of Participants	2.6 Percentage of Participants	2.4 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period Week 24	12.1 Percentage of Participants	8.5 Percentage of Participants	7.7 Percentage of Participants	2.7 Percentage of Participants	2.3 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16 and 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	1.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period Week 24	1.7 Percentage of Participants	0 Percentage of Participants	3.8 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16 and 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=63 Participants 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.	PF-06651600 50 mg QD n=59 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=45 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=57 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period Week 24	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 4	3.1 Percentage of Participants	3.0 Percentage of Participants	1.5 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	3.0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 8	9.4 Percentage of Participants	3.0 Percentage of Participants	4.5 Percentage of Participants	2.0 Percentage of Participants	4.1 Percentage of Participants	4.5 Percentage of Participants
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 12	16.1 Percentage of Participants	9.1 Percentage of Participants	9.1 Percentage of Participants	8.2 Percentage of Participants	8.3 Percentage of Participants	9.1 Percentage of Participants
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 16	14.3 Percentage of Participants	9.7 Percentage of Participants	13.6 Percentage of Participants	8.5 Percentage of Participants	10.6 Percentage of Participants	14.3 Percentage of Participants
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 20	18.0 Percentage of Participants	14.9 Percentage of Participants	17.2 Percentage of Participants	12.2 Percentage of Participants	16.7 Percentage of Participants	17.5 Percentage of Participants
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period Week 24	20.6 Percentage of Participants	21.5 Percentage of Participants	15.4 Percentage of Participants	10.6 Percentage of Participants	18.4 Percentage of Participants	16.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.5 Percentage of Participants
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	3.0 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 12	1.6 Percentage of Participants	3.0 Percentage of Participants	4.5 Percentage of Participants	6.1 Percentage of Participants	2.1 Percentage of Participants	1.5 Percentage of Participants
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 16	3.2 Percentage of Participants	0 Percentage of Participants	4.5 Percentage of Participants	4.3 Percentage of Participants	4.3 Percentage of Participants	7.9 Percentage of Participants
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 20	6.6 Percentage of Participants	1.5 Percentage of Participants	9.4 Percentage of Participants	6.1 Percentage of Participants	6.3 Percentage of Participants	11.1 Percentage of Participants
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period Week 24	11.1 Percentage of Participants	4.6 Percentage of Participants	6.2 Percentage of Participants	4.3 Percentage of Participants	4.1 Percentage of Participants	13.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	1.5 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 12	0 Percentage of Participants	0 Percentage of Participants	1.5 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 16	1.6 Percentage of Participants	0 Percentage of Participants	3.0 Percentage of Participants	2.1 Percentage of Participants	2.1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 20	1.6 Percentage of Participants	1.5 Percentage of Participants	4.7 Percentage of Participants	2.0 Percentage of Participants	2.1 Percentage of Participants	1.6 Percentage of Participants
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period Week 24	1.6 Percentage of Participants	1.5 Percentage of Participants	3.1 Percentage of Participants	0 Percentage of Participants	4.1 Percentage of Participants	1.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 4	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 8	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 12	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 16	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 20	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period Week 24	0 Percentage of Participants	0 Percentage of Participants	1.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 16 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period Week 4	-3.9 Units on a Scale Standard Error 1.34	-2.9 Units on a Scale Standard Error 1.31	-4.4 Units on a Scale Standard Error 1.31	-4.4 Units on a Scale Standard Error 1.50	-3.5 Units on a Scale Standard Error 1.54	-5.1 Units on a Scale Standard Error 1.33
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period Week 16	-6.5 Units on a Scale Standard Error 1.83	-4.9 Units on a Scale Standard Error 1.79	-6.3 Units on a Scale Standard Error 1.82	-4.8 Units on a Scale Standard Error 2.07	-10.5 Units on a Scale Standard Error 2.06	-7.1 Units on a Scale Standard Error 1.78
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period Week 24	-6.5 Units on a Scale Standard Error 1.99	-3.6 Units on a Scale Standard Error 1.92	-7.7 Units on a Scale Standard Error 1.99	-7.0 Units on a Scale Standard Error 2.30	-9.7 Units on a Scale Standard Error 2.22	-6.4 Units on a Scale Standard Error 1.92

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 16 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period Week 4	-1.2 Units on a Scale Standard Error 0.71	-1.1 Units on a Scale Standard Error 0.69	-1.7 Units on a Scale Standard Error 0.69	-1.8 Units on a Scale Standard Error 0.79	-1.0 Units on a Scale Standard Error 0.81	-2.5 Units on a Scale Standard Error 0.70
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period Week 16	-2.1 Units on a Scale Standard Error 0.88	-1.9 Units on a Scale Standard Error 0.86	-2.6 Units on a Scale Standard Error 0.87	-2.3 Units on a Scale Standard Error 1.00	-4.1 Units on a Scale Standard Error 0.99	-3.1 Units on a Scale Standard Error 0.85
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period Week 24	-1.4 Units on a Scale Standard Error 0.98	-1.7 Units on a Scale Standard Error 0.94	-3.2 Units on a Scale Standard Error 0.97	-2.8 Units on a Scale Standard Error 1.14	-3.9 Units on a Scale Standard Error 1.09	-2.2 Units on a Scale Standard Error 0.94

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 16 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period Week 4	-1.9 Units on a Scale Standard Error 0.56	-1.6 Units on a Scale Standard Error 0.55	-2.4 Units on a Scale Standard Error 0.55	-1.7 Units on a Scale Standard Error 0.62	-1.7 Units on a Scale Standard Error 0.64	-1.8 Units on a Scale Standard Error 0.56
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period Week 16	-3.4 Units on a Scale Standard Error 0.71	-2.3 Units on a Scale Standard Error 0.70	-3.2 Units on a Scale Standard Error 0.71	-1.7 Units on a Scale Standard Error 0.80	-4.3 Units on a Scale Standard Error 0.80	-2.9 Units on a Scale Standard Error 0.69
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period Week 24	-3.8 Units on a Scale Standard Error 0.76	-2.1 Units on a Scale Standard Error 0.73	-3.7 Units on a Scale Standard Error 0.76	-3.1 Units on a Scale Standard Error 0.88	-4.5 Units on a Scale Standard Error 0.84	-3.2 Units on a Scale Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 16 and 24

Population: 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.

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).

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=64 Participants 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.	PF-06651600 100 mg - 50 mg QD n=67 Participants 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.	PF-06651600 50 mg QD n=67 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 Participants Participants were randomized to receive placebo for 24 weeks.
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period Week 16	-1.1 Units on a Scale Standard Error 0.50	-0.8 Units on a Scale Standard Error 0.49	-0.5 Units on a Scale Standard Error 0.50	-0.9 Units on a Scale Standard Error 0.57	-2.1 Units on a Scale Standard Error 0.56	-1.0 Units on a Scale Standard Error 0.49
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period Week 24	-1.4 Units on a Scale Standard Error 0.53	0 Units on a Scale Standard Error 0.52	-0.7 Units on a Scale Standard Error 0.53	-1.3 Units on a Scale Standard Error 0.62	-1.3 Units on a Scale Standard Error 0.60	-0.9 Units on a Scale Standard Error 0.51
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period Week 4	-0.8 Units on a Scale Standard Error 0.37	-0.3 Units on a Scale Standard Error 0.36	-0.2 Units on a Scale Standard Error 0.36	-0.9 Units on a Scale Standard Error 0.41	-0.7 Units on a Scale Standard Error 0.42	-0.7 Units on a Scale Standard Error 0.37

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	PF-06651600 200 mg - 50 mg QD n=62 Participants 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.	PF-06651600 100 mg - 50 mg QD n=64 Participants 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.	PF-06651600 50 mg QD n=65 Participants Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=46 Participants Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=48 Participants Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=65 Participants Participants were randomized to receive placebo for 24 weeks.
Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

Adverse Events

PF-06651600 200 mg - 50 mg QD

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

PF-06651600 100 mg - 50 mg QD

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

PF-06651600 50 mg QD

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

PF-06651600 30 mg QD

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

PF-06651600 10 mg QD

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Extension (EXT) PF-06700841 60 mg - 30 mg QD

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

EX PF-06651600 200 mg - 50 mg QD + nbUVB

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

EX PF-06651600 200mg-50mg QD

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

EX PF-06651600 50mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

EXT PF-06651600 30 mg QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-06651600 200 mg - 50 mg QD n=65 participants at risk 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.	PF-06651600 100 mg - 50 mg QD n=67 participants at risk 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.	PF-06651600 50 mg QD n=67 participants at risk Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 participants at risk Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 participants at risk Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 participants at risk Participants were randomized to receive placebo for 24 weeks.	Extension (EXT) PF-06700841 60 mg - 30 mg QD n=55 participants at risk 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.	EX PF-06651600 200 mg - 50 mg QD + nbUVB n=43 participants at risk 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.	EX PF-06651600 200mg-50mg QD n=187 participants at risk 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.	EX PF-06651600 50mg QD n=6 participants at risk 50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.	EXT PF-06651600 30 mg QD n=2 participants at risk Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	2.0% 1/50 • Number of events 1 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Nervous system disorders Migraine	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Renal and urinary disorders Neurogenic bladder	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	1.5% 1/66 • Number of events 1 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Disseminated varicella zoster virus infection	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	1.8% 1/55 • Number of events 1 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.53% 1/187 • Number of events 1 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.

Other adverse events

Measure	PF-06651600 200 mg - 50 mg QD n=65 participants at risk 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.	PF-06651600 100 mg - 50 mg QD n=67 participants at risk 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.	PF-06651600 50 mg QD n=67 participants at risk Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.	PF-06651600 30 mg QD n=50 participants at risk Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.	PF-06651600 10 mg QD n=49 participants at risk Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.	Placebo n=66 participants at risk Participants were randomized to receive placebo for 24 weeks.	Extension (EXT) PF-06700841 60 mg - 30 mg QD n=55 participants at risk 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.	EX PF-06651600 200 mg - 50 mg QD + nbUVB n=43 participants at risk 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.	EX PF-06651600 200mg-50mg QD n=187 participants at risk 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.	EX PF-06651600 50mg QD n=6 participants at risk 50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.	EXT PF-06651600 30 mg QD n=2 participants at risk Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Musculoskeletal and connective tissue disorders Spinal segmental dysfunction	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	5.5% 3/55 • Number of events 3 • 48 weeks 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.	4.7% 2/43 • Number of events 2 • 48 weeks 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.	1.6% 3/187 • Number of events 3 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/65 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	3.0% 2/67 • Number of events 3 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	6.1% 4/66 • Number of events 4 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/65 • 48 weeks 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.	7.5% 5/67 • Number of events 7 • 48 weeks 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.	3.0% 2/67 • Number of events 2 • 48 weeks 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.	8.0% 4/50 • Number of events 5 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	1.5% 1/66 • Number of events 2 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Gastrointestinal disorders Dyspepsia	1.5% 1/65 • Number of events 1 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	6.1% 3/49 • Number of events 4 • 48 weeks 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.	4.5% 3/66 • Number of events 3 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
General disorders Fatigue	9.2% 6/65 • Number of events 6 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	3.0% 2/67 • Number of events 2 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	1.5% 1/66 • Number of events 1 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Bronchitis	0.00% 0/65 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	6.0% 3/50 • Number of events 6 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	1.8% 1/55 • Number of events 1 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	50.0% 1/2 • Number of events 1 • 48 weeks 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.
Infections and infestations Folliculitis	0.00% 0/65 • 48 weeks 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.	1.5% 1/67 • Number of events 2 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	2.0% 1/50 • Number of events 1 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	6.1% 4/66 • Number of events 4 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Gastroenteritis	3.1% 2/65 • Number of events 2 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	6.0% 3/50 • Number of events 3 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	1.5% 1/66 • Number of events 1 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Nasopharyngitis	12.3% 8/65 • Number of events 9 • 48 weeks 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.	14.9% 10/67 • Number of events 11 • 48 weeks 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.	23.9% 16/67 • Number of events 20 • 48 weeks 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.	10.0% 5/50 • Number of events 8 • 48 weeks 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.	10.2% 5/49 • Number of events 5 • 48 weeks 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.	21.2% 14/66 • Number of events 20 • 48 weeks 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.	5.5% 3/55 • Number of events 3 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	4.3% 8/187 • Number of events 10 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Upper respiratory tract infection	7.7% 5/65 • Number of events 6 • 48 weeks 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.	14.9% 10/67 • Number of events 11 • 48 weeks 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.	7.5% 5/67 • Number of events 8 • 48 weeks 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.	16.0% 8/50 • Number of events 8 • 48 weeks 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.	12.2% 6/49 • Number of events 7 • 48 weeks 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.	12.1% 8/66 • Number of events 8 • 48 weeks 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.	7.3% 4/55 • Number of events 4 • 48 weeks 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.	4.7% 2/43 • Number of events 2 • 48 weeks 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.	4.8% 9/187 • Number of events 10 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Urinary tract infection	6.2% 4/65 • Number of events 5 • 48 weeks 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.	6.0% 4/67 • Number of events 6 • 48 weeks 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.	3.0% 2/67 • Number of events 2 • 48 weeks 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.	4.0% 2/50 • Number of events 2 • 48 weeks 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.	6.1% 3/49 • Number of events 3 • 48 weeks 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.	4.5% 3/66 • Number of events 3 • 48 weeks 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.	1.8% 1/55 • Number of events 2 • 48 weeks 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.	7.0% 3/43 • Number of events 4 • 48 weeks 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.	6.4% 12/187 • Number of events 16 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	50.0% 1/2 • Number of events 1 • 48 weeks 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.
Musculoskeletal and connective tissue disorders Back pain	4.6% 3/65 • Number of events 3 • 48 weeks 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.	4.5% 3/67 • Number of events 3 • 48 weeks 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.	9.0% 6/67 • Number of events 8 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	4.5% 3/66 • Number of events 3 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Nervous system disorders Headache	6.2% 4/65 • Number of events 4 • 48 weeks 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.	10.4% 7/67 • Number of events 9 • 48 weeks 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.	11.9% 8/67 • Number of events 8 • 48 weeks 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.	2.0% 1/50 • Number of events 2 • 48 weeks 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.	8.2% 4/49 • Number of events 5 • 48 weeks 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.	12.1% 8/66 • Number of events 10 • 48 weeks 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.	7.3% 4/55 • Number of events 4 • 48 weeks 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.	7.0% 3/43 • Number of events 3 • 48 weeks 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.	4.3% 8/187 • Number of events 8 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Acne	6.2% 4/65 • Number of events 4 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	6.0% 4/67 • Number of events 4 • 48 weeks 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.	2.0% 1/50 • Number of events 1 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Dry skin	1.5% 1/65 • Number of events 1 • 48 weeks 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.	6.0% 4/67 • Number of events 4 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	4.0% 2/50 • Number of events 2 • 48 weeks 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.	2.0% 1/49 • Number of events 1 • 48 weeks 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.	3.0% 2/66 • Number of events 2 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Pruritus	4.6% 3/65 • Number of events 3 • 48 weeks 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.	3.0% 2/67 • Number of events 2 • 48 weeks 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.	3.0% 2/67 • Number of events 2 • 48 weeks 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.	2.0% 1/50 • Number of events 1 • 48 weeks 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.	4.1% 2/49 • Number of events 2 • 48 weeks 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.	7.6% 5/66 • Number of events 5 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	7.0% 3/43 • Number of events 3 • 48 weeks 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.	2.7% 5/187 • Number of events 6 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Urticaria	3.1% 2/65 • Number of events 3 • 48 weeks 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.	4.5% 3/67 • Number of events 6 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	6.1% 3/49 • Number of events 4 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Ear and labyrinth disorders Ear pain	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
General disorders Influenza like illness	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations COVID-19	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	1.1% 2/187 • Number of events 2 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	50.0% 1/2 • Number of events 1 • 48 weeks 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.
Infections and infestations Influenza	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	5.5% 3/55 • Number of events 3 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	1.1% 2/187 • Number of events 2 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Infections and infestations Onychomycosis	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	50.0% 1/2 • Number of events 1 • 48 weeks 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.
Investigations Blood creatine phosphokinase increased	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	5.5% 3/55 • Number of events 3 • 48 weeks 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.	9.3% 4/43 • Number of events 5 • 48 weeks 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.	1.6% 3/187 • Number of events 3 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	7.0% 3/43 • Number of events 4 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	2.3% 1/43 • Number of events 1 • 48 weeks 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.	0.53% 1/187 • Number of events 3 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	50.0% 1/2 • Number of events 1 • 48 weeks 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.
Vascular disorders Hypertension	0.00% 0/65 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	0.00% 0/50 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	0.00% 0/66 • 48 weeks 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.	1.8% 1/55 • Number of events 1 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	1.1% 2/187 • Number of events 2 • 48 weeks 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.	16.7% 1/6 • Number of events 1 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.
Psychiatric disorders Insomnia	1.5% 1/65 • Number of events 1 • 48 weeks 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.	0.00% 0/67 • 48 weeks 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.	1.5% 1/67 • Number of events 1 • 48 weeks 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.	6.0% 3/50 • Number of events 3 • 48 weeks 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.	0.00% 0/49 • 48 weeks 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.	1.5% 1/66 • Number of events 1 • 48 weeks 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.	0.00% 0/55 • 48 weeks 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.	0.00% 0/43 • 48 weeks 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.	0.00% 0/187 • 48 weeks 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.	0.00% 0/6 • 48 weeks 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.	0.00% 0/2 • 48 weeks 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER