Trial Outcomes & Findings for PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA (NCT NCT04517864)

Results Overview

BAEP interwave I-V latency (in milliseconds) was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Results posted on

2025-07-11

Participant Flow

A total of 131 participants were screened for this study; 71 participants were enrolled and randomized to double-blind treatment and treated. All enrolled participants received tablets until Month 24 and then all but 2 switched to capsules at the start of Extension Phase.

Participant milestones

Participant milestones
Measure	Ritlecitinib 200/50/50 mg QD In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase. In the 15-Month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this phase.	Placebo -> Ritlecitinib 200/50 mg QD In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase. In the 15-month Active Therapy Extension Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD In the treatment period 3 (TP3), participants continued to receive ritlecitinib 50 mg QD during extension phase for 18 months and followed up for 4 weeks post completion or discontinuation of study intervention in the follow-up phase.
Placebo-Controlled Phase STARTED	36	35	0
Placebo-Controlled Phase COMPLETED	32	33	0
Placebo-Controlled Phase NOT COMPLETED	4	2	0
Active Therapy Extension Phase STARTED	32	33	0
Active Therapy Extension Phase COMPLETED	21	24	0
Active Therapy Extension Phase NOT COMPLETED	11	9	0
Extension Phase STARTED	0	0	45
Extension Phase COMPLETED	0	0	0
Extension Phase NOT COMPLETED	0	0	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Ritlecitinib 200/50/50 mg QD In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase. In the 15-Month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this phase.	Placebo -> Ritlecitinib 200/50 mg QD In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase. In the 15-month Active Therapy Extension Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD In the treatment period 3 (TP3), participants continued to receive ritlecitinib 50 mg QD during extension phase for 18 months and followed up for 4 weeks post completion or discontinuation of study intervention in the follow-up phase.
Placebo-Controlled Phase Adverse Event	1	0	0
Placebo-Controlled Phase Lost to Follow-up	1	1	0
Placebo-Controlled Phase Protocol Violation	1	0	0
Placebo-Controlled Phase Withdrawal by Subject	1	1	0
Active Therapy Extension Phase Adverse Event	1	0	0
Active Therapy Extension Phase Lack of Efficacy	1	0	0
Active Therapy Extension Phase Lost to Follow-up	0	1	0
Active Therapy Extension Phase Physician Decision	1	0	0
Active Therapy Extension Phase Withdrawal by Subject	8	8	0
Extension Phase Adverse Event	0	0	1
Extension Phase Lack of Efficacy	0	0	2
Extension Phase Study Terminated By Sponsor	0	0	32
Extension Phase Withdrawal by Subject	0	0	3
Extension Phase Approved Drug Available for Indication	0	0	7

Baseline Characteristics

PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ritlecitinib 200/50/50 mg QD n=36 Participants In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase. In the 15-Month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this phase.	Placebo -> Ritlecitinib 200/50 mg QD n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase. In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Total n=71 Participants Total of all reporting groups
Age, Continuous	35.1 Years STANDARD_DEVIATION 9.64 • n=5 Participants	34.2 Years STANDARD_DEVIATION 8.95 • n=7 Participants	34.7 Years STANDARD_DEVIATION 9.25 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 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
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Percentage of Nerve Fibers With Axonal Swelling	1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.48 • n=5 Participants	1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.07 • n=7 Participants	1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.27 • n=5 Participants
Baseline Intraepidermal Nerve Fiber Density (IENFD)	10.2 fibers/mm STANDARD_DEVIATION 3.81 • n=5 Participants	11.0 fibers/mm STANDARD_DEVIATION 3.95 • n=7 Participants	10.6 fibers/mm STANDARD_DEVIATION 3.87 • n=5 Participants
Baseline Severity of Alopecia Tool (SALT) Scores for Non-AT/AU Participants	59.6 Units on a scale STANDARD_DEVIATION 30.31 • n=5 Participants	53.7 Units on a scale STANDARD_DEVIATION 24.18 • n=7 Participants	56.9 Units on a scale STANDARD_DEVIATION 27.55 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention.

BAEP interwave I-V latency (in milliseconds) was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=31 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=32 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9	0.011 Millisecond (ms) Interval -0.043 to 0.065	-0.010 Millisecond (ms) Interval -0.063 to 0.043	—	—

PRIMARY outcome

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention.

BAEP interwave I-V latency was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=31 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=32 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9	0.031 ms Interval -0.012 to 0.075	0.022 ms Interval -0.02 to 0.065	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6	-0.030 millisecond (ms) Interval -0.072 to 0.011	-0.024 millisecond (ms) Interval -0.065 to 0.017	—	—

SECONDARY outcome

Timeframe: Baseline, Months 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E Month 9E (Month 9 in the Active Therapy Extension Phase)	0.010 millisecond (ms) Standard Deviation 0.1233	-0.033 millisecond (ms) Standard Deviation 0.2448	—	—
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E Month 15E (Month 15 in the Active Therapy Extension Phase)	0.051 millisecond (ms) Standard Deviation 0.1188	0.034 millisecond (ms) Standard Deviation 0.2224	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6	0.021 millisecond (ms) Interval -0.011 to 0.054	-0.020 millisecond (ms) Interval -0.053 to 0.012	—	—

SECONDARY outcome

Timeframe: Baseline, Month 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E Month 9E (Month 9 in the Active Therapy Extension Phase)	0.006 millisecond (ms) Standard Deviation 0.1109	0.056 millisecond (ms) Standard Deviation 0.1694	—	—
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E Month 15E (Month 15 in the Active Therapy Extension Phase)	0.024 millisecond (ms) Standard Deviation 0.1044	0.017 millisecond (ms) Standard Deviation 0.2339	—	—

SECONDARY outcome

Timeframe: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Analysis population included all participants who received at least 1 dose of study intervention.

The endpoint "axonal dystrophy" referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings. IENF was assessed at Day 1 and Month 9. Participants who had entered the Active Therapy Extension Phase at Month 6 had a skin punch biopsy taken at Month 6 for IENF assessments instead of at Month 9. The skin biopsy was collected before the start of Active Therapy Extension Phase.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=32 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=33 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9	0.0 Percentage of Nerve Fibers Interval -0.5 to 2.5	0.0 Percentage of Nerve Fibers Interval -2.0 to 1.0	—	—

SECONDARY outcome

Timeframe: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

The endpoint "axonal dystrophy" referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E	0 Percentage of Nerve Fibers Interval -1.0 to 0.0	0 Percentage of Nerve Fibers Interval -1.0 to 0.0	—	—

SECONDARY outcome

Timeframe: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Analysis population included all participants who received at least 1 dose of study intervention.

IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=32 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=33 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9	-0.4 fibers/mm Standard Deviation 3.90	-0.2 fibers/mm Standard Deviation 2.72	—	—

SECONDARY outcome

Timeframe: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E	0.2 fibers/mm Standard Deviation 2.85	-1.1 fibers/mm Standard Deviation 3.51	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 Month 6	-0.031 Microvolts (μV) Interval -0.063 to 0.0	-0.017 Microvolts (μV) Interval -0.048 to 0.015	—	—
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 Month 9	-0.051 Microvolts (μV) Interval -0.085 to -0.018	0.008 Microvolts (μV) Interval -0.025 to 0.041	—	—

SECONDARY outcome

Timeframe: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E Month 9E (Month 9 in the Active Therapy Extension Phase)	-0.052 μV Standard Deviation 0.1109	-0.025 μV Standard Deviation 0.1649	—	—
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E Month 15E (Month 15 in the Active Therapy Extension Phase)	-0.065 μV Standard Deviation 0.1513	-0.042 μV Standard Deviation 0.1214	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=34 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 Month 6	-0.047 μV Interval -0.082 to -0.013	-0.019 μV Interval -0.053 to 0.015	—	—
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 Month 9	-0.045 μV Interval -0.082 to -0.008	-0.049 μV Interval -0.085 to -0.012	—	—

SECONDARY outcome

Timeframe: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.

High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E Month 9E	-0.058 μV Standard Deviation 0.1209	-0.025 μV Standard Deviation 0.1307	—	—
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E Month 15E	-0.047 μV Standard Deviation 0.1314	-0.023 μV Standard Deviation 0.1217	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. At Month 9, 1 participant in 200/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. The event was unilateral and showed fluctuations in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Baseline - 80 dB of normal hearing level (nHL)	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Baseline - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Baseline - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Baseline - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Baseline - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 6 - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 6 - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 6 - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 6 - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 6 - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 9 - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 9 - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 9 - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 9 - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 Month 9 - 40 dB nHL	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 40 dB nHL	1 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 50 dB nHL	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 9 - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Baseline - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Baseline - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Baseline - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Baseline - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Baseline - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 6 - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 6 - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 6 - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 6 - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 6 - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 9 - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 9 - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 9 - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 Month 9 - 50 dB nHL	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)

Population: Analysis population included all participants who received at least 1 dose of study intervention. 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.

Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Baseline - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 3E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 6E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 9E - 40 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 80 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 70 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 60 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 50 dB nHL	0 Participants	0 Participants	—	—
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E Month 15E - 40 dB nHL	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAE (All-Causality)	29 Participants	22 Participants	3 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAE (Treatment-Related)	9 Participants	5 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAE (All-Causality)	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAE (Treatment-Related)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) Due to All-Causality AEs	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) Due to Treatment-Related AEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This Outcome Measures presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants Who Discontinued Study Drug Due to AE and Continued Study Due to All-Causality AEs	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Discontinued Study Drug Due to AE and Continued Study Due to Treatment-Related AEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Temporary Drug Discontinuation Due to AEs Due to All-Causality AEs	6 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Temporary Drug Discontinuation Due to AEs Due to Treatment-Related AEs	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Clinically Significant Abnormalities in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 16 months

Population: Analysis population included all participants taking at least 1 dose of study intervention.

Safety laboratory assessments included the categories of Hematology, Chemistry, Urinalysis and other tests. The clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 Participants In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=31 Participants In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. 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.

SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 Month 3	-23.0 Units on a scale Interval -29.7 to -16.25	-2.7 Units on a scale Interval -9.39 to 4.06	—	—
Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 Month 6	-35.2 Units on a scale Interval -44.55 to -25.81	-5.1 Units on a scale Interval -14.44 to 4.18	—	—
Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 Month 9	-38.2 Units on a scale Interval -47.46 to -28.86	-6.8 Units on a scale Interval -16.08 to 2.4	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3E, 6E, 9E, 12E and 15E (Month 3, 6, 9, 12 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase.

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. 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.

SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Baseline	69.7 Units on a scale Standard Deviation 31.56	69.6 Units on a scale Standard Deviation 29.59	—	—
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Change at Month 3E	-41.7 Units on a scale Standard Deviation 33.98	-38.7 Units on a scale Standard Deviation 33.49	—	—
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Change at Month 6E	-38.0 Units on a scale Standard Deviation 29.88	-43.4 Units on a scale Standard Deviation 34.13	—	—
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Change at Month 9E	-38.7 Units on a scale Standard Deviation 29.90	-46.6 Units on a scale Standard Deviation 34.14	—	—
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Change at Month 12E	-41.6 Units on a scale Standard Deviation 29.67	-48.9 Units on a scale Standard Deviation 34.77	—	—
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E Change at Month 15E	-44.6 Units on a scale Standard Deviation 28.51	-49.9 Units on a scale Standard Deviation 34.40	—	—

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. 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.

SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score in Placebo-Controlled Phase = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 Month 3	-23.0 Units on a scale Interval -29.7 to -16.25	-2.7 Units on a scale Interval -9.39 to 4.06	—	—
Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 Month 6	-35.2 Units on a scale Interval -44.55 to -25.81	-5.1 Units on a scale Interval -14.44 to 4.18	—	—
Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 Month 9	-38.2 Units on a scale Interval -47.46 to -28.87	-6.8 Units on a scale Interval -16.08 to 2.4	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3E, 6E, 9E, 12E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. 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.

SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Baseline	67.0 Units on a scale Standard Deviation 33.52	69.5 Units on a scale Standard Deviation 29.67	—	—
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Change at Month 3E	-41.7 Units on a scale Standard Deviation 33.97	-39.4 Units on a scale Standard Deviation 32.89	—	—
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Change at Month 6E	-38.0 Units on a scale Standard Deviation 29.87	-44.2 Units on a scale Standard Deviation 33.37	—	—
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Change at Month 9E	-38.7 Units on a scale Standard Deviation 29.90	-47.4 Units on a scale Standard Deviation 33.36	—	—
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Change at Month 12E	-41.6 Units on a scale Standard Deviation 29.70	-49.7 Units on a scale Standard Deviation 33.92	—	—
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E Change at Month 15E	-44.8 Units on a scale Standard Deviation 28.37	-50.8 Units on a scale Standard Deviation 33.49	—	—

SECONDARY outcome

Timeframe: Months 1, 3, 6 and 9

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention.

The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, "Since the start of the study, my alopecia areata has: …". The participants selected one of seven responses ranging from "greatly improved" to "greatly worsened". This Outcome Measure presented the number of participants with PGI-C response which was defined as "greatly improved" or "moderately improved". Participants with missing PGI-C scores were considered as non-responders.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 Month 1	4 Participants	3 Participants	—	—
Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 Month 3	20 Participants	6 Participants	—	—
Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 Month 6	21 Participants	10 Participants	—	—
Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 Month 9	19 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Month 3E, 6E, 9E, 12E and 15E

Population: Analysis population included all randomized participants taking at least 1 dose of study intervention.

The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, "Since the start of the study, my alopecia areata has: …". The participants selected one of seven responses ranging from "greatly improved" to "greatly worsened". This Outcome Measure presented the number of participants with PGI-C response which was defined as "greatly improved" or "moderately improved". Participants with missing PGI-C scores were considered as non-responders.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=36 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo n=35 Participants In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E Month 3E	22 Participants	22 Participants	—	—
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E Month 6E	16 Participants	20 Participants	—	—
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E Month 9E	20 Participants	18 Participants	—	—
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E Month 12E	17 Participants	18 Participants	—	—
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E Month 15E	17 Participants	18 Participants	—	—

SECONDARY outcome

Timeframe: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of SAE. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) TEAEs	19 Participants	—	—	—
Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) TESAEs	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants Who Discontinued From Study Due to AEs: Extension Phase (TP3)	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This outcome measure presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants Who Discontinued Study Drug Due to AE and Continued Study: Extension Phase (TP3)	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Temporary Drug Discontinuation Due to AEs: Extension Phase (TP3)	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From screening up to 28 days follow up after last dose of study treatment (maximum up to 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants were refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Clinically Significant Abnormalities in Vital Signs: Extension Phase (TP3)	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From screening up to 28 days after last dose of study treatment (maximum up to 19 months)

Population: Analysis population included all participants taking at least 1 dose of study intervention.

Safety laboratory assessments included the categories of hematology, chemistry, urinalysis and other tests. The clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Ritlecitinib 200/50 mg QD n=45 Participants In the 9-month Placebo-Controlled Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received 1 tablet QD of Ritlecitinib 50 mg and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this phase.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values: Extension Phase (TP3)	0 Participants	—	—	—

Adverse Events

Ritlecitinib 200/50 mg QD - Placebo-Controlled Phase

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo - Placebo-Controlled Phase

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Ritlecitinib 50 mg QD - Active Therapy Extension Phase

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Ritlecitinib 50 mg QD: Extension Phase

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ritlecitinib 200/50 mg QD - Placebo-Controlled Phase n=36 participants at risk In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo - Placebo-Controlled Phase n=35 participants at risk In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 participants at risk In the 15-month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=33 participants at risk In the 15-month Active Therapy Extension Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD: Extension Phase n=45 participants at risk In the treatment period 3 (TP3), participants continued to receive ritlecitinib 50 mg QD during extension phase for 18 months and followed up for 4 weeks post completion or discontinuation of study intervention in the follow-up phase.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Vascular disorders Takayasu's arteritis	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.1% 1/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.1% 1/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Skin and subcutaneous tissue disorders Chronic pigmented purpura	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.0% 1/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Hepatobiliary disorders Biliary colic	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.2% 1/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.

Other adverse events

Other adverse events
Measure	Ritlecitinib 200/50 mg QD - Placebo-Controlled Phase n=36 participants at risk In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Placebo - Placebo-Controlled Phase n=35 participants at risk In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD - Active Therapy Extension Phase n=32 participants at risk In the 15-month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase n=33 participants at risk In the 15-month Active Therapy Extension Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase.	Ritlecitinib 50 mg QD: Extension Phase n=45 participants at risk In the treatment period 3 (TP3), participants continued to receive ritlecitinib 50 mg QD during extension phase for 18 months and followed up for 4 weeks post completion or discontinuation of study intervention in the follow-up phase.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	5.7% 2/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Ear and labyrinth disorders Tinnitus	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Gastrointestinal disorders Diarrhoea	8.3% 3/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.2% 1/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Gastrointestinal disorders Nausea	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	8.6% 3/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Gastrointestinal disorders Vomiting	8.3% 3/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.1% 1/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Acne pustular	11.1% 4/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations COVID-19	8.3% 3/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	8.6% 3/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	15.6% 5/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	18.2% 6/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.2% 1/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Nasopharyngitis	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	9.4% 3/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.1% 2/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	4.4% 2/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Sinusitis	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.0% 1/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Tonsillitis	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.2% 1/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Upper respiratory tract infection	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.1% 1/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.1% 2/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	4.4% 2/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	5.7% 2/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.2% 2/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.0% 1/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Injury, poisoning and procedural complications Limb injury	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	5.7% 2/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Investigations Blood creatine phosphokinase increased	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Nervous system disorders Dizziness	8.3% 3/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Nervous system disorders Headache	11.1% 4/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	9.1% 3/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Nervous system disorders Hypoaesthesia	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	8.6% 3/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.2% 2/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Psychiatric disorders Insomnia	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Skin and subcutaneous tissue disorders Acne	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	5.7% 2/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.0% 1/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	4.4% 2/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	5.7% 2/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Laryngitis	0.00% 0/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.1% 2/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Infections and infestations Pharyngitis	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.2% 2/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 2/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Nervous system disorders Paraesthesia	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	2.9% 1/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	9.4% 3/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Vascular disorders Hypertension	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.2% 2/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	2.8% 1/36 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	0.00% 0/35 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.1% 1/32 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	3.0% 1/33 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.	6.7% 3/45 • Placebo controlled phase (TP1) & Active therapy extension phase (TP2): 24 months, Extension phase (TP3): From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) Same event may appear as both an AE and SAE.However,what is presented are distinct events.Event may be categorized as serious in 1 participant,as non-serious in another participant,or 1 participant may have experienced both serious and non-serious event during study.Analysis population=all participants taking at least 1dose of study intervention.

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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.
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