Trial Outcomes & Findings for PF-06651600 for the Treatment of Alopecia Areata (NCT NCT03732807)

Last Updated: 2022-02-24

Results Overview

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (\<=) 20 at week 24 were reported.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

718 participants

Primary outcome timeframe

Week 24

Results posted on

2022-02-24

Participant Flow

Total 1097 participants signed the informed consent form. Out of which 379 participants were screen failures, 718 actually enrolled into the study and were assigned to study treatments.

Participant milestones

Participant milestones
Measure	Ritlecitinib (PF-06651600) 200 mg Then 50 mg Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (\>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Treatment Period (up to Week 24) STARTED	132	130	130	132	63	65	66
Treatment Period (up to Week 24) COMPLETED	122	124	121	117	58	63	61
Treatment Period (up to Week 24) NOT COMPLETED	10	6	9	15	5	2	5
Treatment Extension (Week 25 up to 48) STARTED	113	111	108	106	49	59	57
Treatment Extension (Week 25 up to 48) COMPLETED	107	100	103	97	44	56	53
Treatment Extension (Week 25 up to 48) NOT COMPLETED	6	11	5	9	5	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ritlecitinib (PF-06651600) 200 mg Then 50 mg Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (\>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Treatment Period (up to Week 24) Adverse Event	3	0	2	4	2	0	1
Treatment Period (up to Week 24) Lost to Follow-up	1	0	1	2	1	0	0
Treatment Period (up to Week 24) Physician Decision	0	1	2	5	0	0	1
Treatment Period (up to Week 24) Pregnancy	1	0	0	0	1	0	1
Treatment Period (up to Week 24) Protocol Violation	1	1	0	0	0	0	0
Treatment Period (up to Week 24) Withdrawal by Subject	4	4	4	4	1	1	2
Treatment Period (up to Week 24) Lack of Efficacy	0	0	0	0	0	1	0
Treatment Extension (Week 25 up to 48) Adverse Event	0	2	2	1	0	0	2
Treatment Extension (Week 25 up to 48) Lack of Efficacy	2	1	0	3	3	0	1
Treatment Extension (Week 25 up to 48) Lost to Follow-up	0	0	2	1	1	2	0
Treatment Extension (Week 25 up to 48) Non-Compliant with study drug	0	1	0	0	0	0	0
Treatment Extension (Week 25 up to 48) Physician Decision	0	1	0	1	1	0	0
Treatment Extension (Week 25 up to 48) Withdrawal by Subject	3	2	1	1	0	1	1
Treatment Extension (Week 25 up to 48) Other	1	4	0	2	0	0	0

Baseline Characteristics

PF-06651600 for the Treatment of Alopecia Areata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Total n=718 Participants Total of all reporting groups
Age, Continuous	34.5 Years STANDARD_DEVIATION 14.98 • n=5 Participants	33.7 Years STANDARD_DEVIATION 13.75 • n=7 Participants	32.4 Years STANDARD_DEVIATION 13.36 • n=5 Participants	33.7 Years STANDARD_DEVIATION 14.83 • n=4 Participants	34.3 Years STANDARD_DEVIATION 13.88 • n=21 Participants	33.0 Years STANDARD_DEVIATION 14.01 • n=8 Participants	35.0 Years STANDARD_DEVIATION 15.89 • n=8 Participants	33.8 Years STANDARD_DEVIATION 14.33 • n=24 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	85 Participants n=7 Participants	71 Participants n=5 Participants	80 Participants n=4 Participants	43 Participants n=21 Participants	46 Participants n=8 Participants	40 Participants n=8 Participants	446 Participants n=24 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	45 Participants n=7 Participants	59 Participants n=5 Participants	52 Participants n=4 Participants	20 Participants n=21 Participants	19 Participants n=8 Participants	26 Participants n=8 Participants	272 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	11 Participants n=5 Participants	23 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	87 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants	114 Participants n=7 Participants	116 Participants n=5 Participants	109 Participants n=4 Participants	55 Participants n=21 Participants	58 Participants n=8 Participants	61 Participants n=8 Participants	626 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Asian	33 Participants n=5 Participants	28 Participants n=7 Participants	43 Participants n=5 Participants	34 Participants n=4 Participants	17 Participants n=21 Participants	14 Participants n=8 Participants	17 Participants n=8 Participants	186 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	27 Participants n=24 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	90 Participants n=7 Participants	79 Participants n=5 Participants	91 Participants n=4 Participants	42 Participants n=21 Participants	47 Participants n=8 Participants	47 Participants n=8 Participants	488 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	8 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants

PRIMARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Participants with missing SALT scores due to coronavirus disease-19 related reasons were excluded from this analysis, while participants with missing data due to other reasons were considered as non-responders. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=121 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=59 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24	1.54 Percentage of participants Interval 0.0 to 3.65	30.65 Percentage of participants Interval 22.53 to 38.76	22.31 Percentage of participants Interval 14.9 to 29.73	23.39 Percentage of participants Interval 15.94 to 30.84	14.29 Percentage of participants Interval 8.0 to 20.57	1.69 Percentage of participants Interval 0.0 to 4.99	—

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 4: Data imputed by using a missing at random (MAR) mechanism for participants with missing data due to COVID-19. Missing data due to reasons not related to COVID-19 were consider as non-responders.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=125 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=118 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=114 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=55 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4	1.54 Percentage of participants	21.29 Percentage of participants	12.87 Percentage of participants	13.42 Percentage of participants	10.62 Percentage of participants	1.65 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 1: Participants with missing SALT score at Week 24 due to COVID-19 related reasons excluded from analysis at that time point, participants with missing SALT scores due to other reasons counted as non-responders at that time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=121 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=59 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1	1.54 Percentage of participants Interval 0.0 to 3.65	21.77 Percentage of participants Interval 14.51 to 29.04	13.22 Percentage of participants Interval 7.19 to 19.26	13.71 Percentage of participants Interval 7.66 to 19.76	10.92 Percentage of participants Interval 5.32 to 16.53	1.69 Percentage of participants Interval 0.0 to 4.99	—

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=125 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=120 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=120 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=116 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=55 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24	9.23 Percentage of participants	52.19 Percentage of participants	45.40 Percentage of participants	49.17 Percentage of participants	41.95 Percentage of participants	11.36 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score \<=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT \<=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=121 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=59 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model	1.63 Percentage of participants	32.37 Percentage of participants	20.57 Percentage of participants	22.52 Percentage of participants	13.58 Percentage of participants	4.81 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score \<=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT \<=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=121 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=124 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=119 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=59 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model	1.66 Percentage of participants	21.29 Percentage of participants	13.76 Percentage of participants	14.43 Percentage of participants	9.02 Percentage of participants	3.88 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 4	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.78 Percentage of participants Interval 0.0 to 2.29	0.00 Percentage of participants 95% confidence interval (CI) could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 8	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	5.47 Percentage of participants Interval 1.53 to 9.41	4.13 Percentage of participants Interval 0.59 to 7.68	2.46 Percentage of participants Interval 0.0 to 5.21	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=20.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 28	1.75 Percentage of participants Interval 0.0 to 5.16	34.17 Percentage of participants Interval 25.68 to 42.65	23.53 Percentage of participants Interval 15.91 to 31.15	26.05 Percentage of participants Interval 18.16 to 33.94	20.49 Percentage of participants Interval 13.33 to 27.65	5.00 Percentage of participants Interval 0.0 to 10.51	6.35 Percentage of participants Interval 0.33 to 12.37
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 12	1.64 Percentage of participants Interval 0.0 to 4.83	11.90 Percentage of participants Interval 6.25 to 17.56	8.87 Percentage of participants Interval 3.87 to 13.88	6.35 Percentage of participants Interval 2.09 to 10.61	3.28 Percentage of participants Interval 0.12 to 6.44	3.39 Percentage of participants Interval 0.0 to 8.01	1.59 Percentage of participants Interval 0.0 to 4.67
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 18	1.67 Percentage of participants Interval 0.0 to 4.91	19.83 Percentage of participants Interval 12.73 to 26.94	13.22 Percentage of participants Interval 7.19 to 19.26	13.11 Percentage of participants Interval 7.12 to 19.1	9.40 Percentage of participants Interval 4.11 to 14.69	3.33 Percentage of participants Interval 0.0 to 7.88	1.61 Percentage of participants Interval 0.0 to 4.75
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 34	19.67 Percentage of participants Interval 9.7 to 29.65	38.40 Percentage of participants Interval 29.87 to 46.93	27.64 Percentage of participants Interval 19.74 to 35.55	33.87 Percentage of participants Interval 25.54 to 42.2	28.69 Percentage of participants Interval 20.66 to 36.71	5.08 Percentage of participants Interval 0.0 to 10.69	9.23 Percentage of participants Interval 2.19 to 16.27
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 40	23.08 Percentage of participants Interval 12.83 to 33.32	39.06 Percentage of participants Interval 30.61 to 47.51	33.33 Percentage of participants Interval 25.0 to 41.66	39.34 Percentage of participants Interval 30.68 to 48.01	30.00 Percentage of participants Interval 21.8 to 38.2	6.78 Percentage of participants Interval 0.36 to 13.19	15.38 Percentage of participants Interval 6.61 to 24.16
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 48	33.85 Percentage of participants Interval 22.34 to 45.35	39.53 Percentage of participants Interval 31.1 to 47.97	34.43 Percentage of participants Interval 26.0 to 42.86	43.20 Percentage of participants Interval 34.52 to 51.88	31.15 Percentage of participants Interval 22.93 to 39.37	9.84 Percentage of participants Interval 2.36 to 17.31	18.75 Percentage of participants Interval 9.19 to 28.31

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 28	1.75 Percentage of participants Interval 0.0 to 5.16	29.17 Percentage of participants Interval 21.03 to 37.3	16.81 Percentage of participants Interval 10.09 to 23.53	18.49 Percentage of participants Interval 11.51 to 25.46	16.39 Percentage of participants Interval 9.82 to 22.96	3.33 Percentage of participants Interval 0.0 to 7.88	3.17 Percentage of participants Interval 0.0 to 7.5
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 4	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.78 Percentage of participants Interval 0.0 to 2.29	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 8	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	2.34 Percentage of participants Interval 0.0 to 4.96	0.83 Percentage of participants Interval 0.0 to 2.44	0.82 Percentage of participants Interval 0.0 to 2.42	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 18	1.67 Percentage of participants Interval 0.0 to 4.91	12.40 Percentage of participants Interval 6.52 to 18.27	7.44 Percentage of participants Interval 2.76 to 12.11	6.56 Percentage of participants Interval 2.16 to 10.95	5.13 Percentage of participants Interval 1.13 to 9.12	1.67 Percentage of participants Interval 0.0 to 4.91	1.61 Percentage of participants Interval 0.0 to 4.75
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 34	13.11 Percentage of participants Interval 4.64 to 21.59	30.40 Percentage of participants Interval 22.34 to 38.46	18.70 Percentage of participants Interval 11.81 to 25.59	23.39 Percentage of participants Interval 15.94 to 30.84	22.13 Percentage of participants Interval 14.76 to 29.5	3.39 Percentage of participants Interval 0.0 to 8.01	4.62 Percentage of participants Interval 0.0 to 9.72
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 40	18.46 Percentage of participants Interval 9.03 to 27.89	31.25 Percentage of participants Interval 23.22 to 39.28	25.20 Percentage of participants Interval 17.53 to 32.88	27.05 Percentage of participants Interval 19.17 to 34.93	25.00 Percentage of participants Interval 17.25 to 32.75	3.39 Percentage of participants Interval 0.0 to 8.01	9.23 Percentage of participants Interval 2.19 to 16.27
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 48	24.62 Percentage of participants Interval 14.14 to 35.09	33.33 Percentage of participants Interval 25.2 to 41.47	27.87 Percentage of participants Interval 19.91 to 35.82	31.20 Percentage of participants Interval 23.08 to 39.32	25.41 Percentage of participants Interval 17.68 to 33.14	6.56 Percentage of participants Interval 0.35 to 12.77	14.06 Percentage of participants Interval 5.55 to 22.58
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 Week 12	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with SALT score \<=10.	6.35 Percentage of participants Interval 2.09 to 10.61	5.65 Percentage of participants Interval 1.58 to 9.71	5.56 Percentage of participants Interval 1.56 to 9.56	0.82 Percentage of participants Interval 0.0 to 2.42	1.69 Percentage of participants Interval 0.0 to 4.99	1.59 Percentage of participants Interval 0.0 to 4.67

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 24	1.54 Percentage of participants Interval 0.0 to 4.53	31.45 Percentage of participants Interval 23.28 to 39.62	20.66 Percentage of participants Interval 13.45 to 27.88	22.58 Percentage of participants Interval 15.22 to 29.94	13.45 Percentage of participants Interval 7.32 to 19.57	1.69 Percentage of participants Interval 0.0 to 4.99	3.08 Percentage of participants Interval 0.0 to 7.28
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 4	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.78 Percentage of participants Interval 0.0 to 2.29	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 12	1.64 Percentage of participants Interval 0.0 to 4.83	11.90 Percentage of participants Interval 6.25 to 17.56	8.06 Percentage of participants Interval 3.27 to 12.86	6.35 Percentage of participants Interval 2.09 to 10.61	2.46 Percentage of participants Interval 0.0 to 5.21	1.69 Percentage of participants Interval 0.0 to 4.99	1.59 Percentage of participants Interval 0.0 to 4.67
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 40	23.08 Percentage of participants Interval 12.83 to 33.32	39.84 Percentage of participants Interval 31.36 to 48.33	34.96 Percentage of participants Interval 26.53 to 43.39	42.62 Percentage of participants Interval 33.85 to 51.4	30.00 Percentage of participants Interval 21.8 to 38.2	5.08 Percentage of participants Interval 0.0 to 10.69	15.38 Percentage of participants Interval 6.61 to 24.16
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 8	1.59 Percentage of participants Interval 0.0 to 4.67	4.69 Percentage of participants Interval 1.03 to 8.35	3.31 Percentage of participants Interval 0.12 to 6.49	1.64 Percentage of participants Interval 0.0 to 3.89	0.83 Percentage of participants Interval 0.0 to 2.44	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 18	1.67 Percentage of participants Interval 0.0 to 4.91	20.66 Percentage of participants Interval 13.45 to 27.88	14.88 Percentage of participants Interval 8.54 to 21.22	9.84 Percentage of participants Interval 4.55 to 15.12	11.11 Percentage of participants Interval 5.42 to 16.81	1.67 Percentage of participants Interval 0.0 to 4.91	1.61 Percentage of participants Interval 0.0 to 4.75
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 28	3.51 Percentage of participants Interval 0.0 to 8.29	34.17 Percentage of participants Interval 25.68 to 42.65	24.37 Percentage of participants Interval 16.66 to 32.08	27.73 Percentage of participants Interval 19.69 to 35.77	21.31 Percentage of participants Interval 14.04 to 28.58	5.00 Percentage of participants Interval 0.0 to 10.51	4.76 Percentage of participants Interval 0.0 to 10.02
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 34	21.31 Percentage of participants Interval 11.03 to 31.59	38.40 Percentage of participants Interval 29.87 to 46.93	32.52 Percentage of participants Interval 24.24 to 40.8	38.71 Percentage of participants Interval 30.14 to 47.28	28.69 Percentage of participants Interval 20.66 to 36.71	5.08 Percentage of participants Interval 0.0 to 10.69	10.77 Percentage of participants Interval 3.23 to 18.31
Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 48	32.31 Percentage of participants Interval 20.94 to 43.68	39.53 Percentage of participants Interval 31.1 to 47.97	36.07 Percentage of participants Interval 27.54 to 44.59	46.40 Percentage of participants Interval 37.66 to 55.14	31.15 Percentage of participants Interval 22.93 to 39.37	9.84 Percentage of participants Interval 2.36 to 17.31	21.88 Percentage of participants Interval 11.75 to 32.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 8, 12, 18, and 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 Change at Week 8	-1.2 Units on a scale Interval -3.99 to 1.5	-12.8 Units on a scale Interval -15.56 to -10.05	-12.5 Units on a scale Interval -15.28 to -9.71	-6.3 Units on a scale Interval -9.1 to -3.5	-5.0 Units on a scale Interval -7.82 to -2.21	-1.7 Units on a scale Interval -5.74 to 2.34	—
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 Change at Week 12	-2.4 Units on a scale Interval -6.12 to 1.35	-22.7 Units on a scale Interval -26.47 to -18.97	-20.1 Units on a scale Interval -23.87 to -16.3	-12.4 Units on a scale Interval -16.18 to -8.61	-10.3 Units on a scale Interval -14.11 to -6.47	-3.5 Units on a scale Interval -9.0 to 1.98	—
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 Change at Week 24	-5.1 Units on a scale Interval -10.03 to -0.13	-36.5 Units on a scale Interval -41.54 to -31.53	-29.2 Units on a scale Interval -34.21 to -24.15	-33.3 Units on a scale Interval -38.33 to -28.25	-23.6 Units on a scale Interval -28.72 to -18.45	-4.2 Units on a scale Interval -11.5 to 3.13	—
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 Change at Week 4	-0.9 Units on a scale Interval -2.17 to 0.46	-2.3 Units on a scale Interval -3.64 to -1.01	-2.7 Units on a scale Interval -4.03 to -1.35	-1.8 Units on a scale Interval -3.16 to -0.5	-1.3 Units on a scale Interval -2.6 to 0.06	-1.3 Units on a scale Interval -3.19 to 0.69	—
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 Change at Week 18	-3.9 Units on a scale Interval -8.31 to 0.43	-31.2 Units on a scale Interval -35.63 to -26.83	-25.0 Units on a scale Interval -29.41 to -20.55	-22.5 Units on a scale Interval -26.94 to -18.07	-17.5 Units on a scale Interval -22.02 to -13.02	-2.4 Units on a scale Interval -8.87 to 3.97	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in SALT Score at Week 28, 34, 40, and 48 Change at Week 28	-11.5 Units on a scale Standard Deviation 22.75	-44.1 Units on a scale Standard Deviation 36.35	-33.3 Units on a scale Standard Deviation 33.85	-36.1 Units on a scale Standard Deviation 33.42	-29.2 Units on a scale Standard Deviation 32.56	-5.6 Units on a scale Standard Deviation 23.15	-5.0 Units on a scale Standard Deviation 18.51
Change From Baseline in SALT Score at Week 28, 34, 40, and 48 Change at Week 40	-36.5 Units on a scale Standard Deviation 34.56	-49.3 Units on a scale Standard Deviation 36.11	-38.5 Units on a scale Standard Deviation 37.14	-46.9 Units on a scale Standard Deviation 35.68	-35.9 Units on a scale Standard Deviation 35.90	-11.4 Units on a scale Standard Deviation 26.01	-23.0 Units on a scale Standard Deviation 30.64
Change From Baseline in SALT Score at Week 28, 34, 40, and 48 Change at Week 48	-46.3 Units on a scale Standard Deviation 35.51	-49.4 Units on a scale Standard Deviation 36.09	-40.5 Units on a scale Standard Deviation 37.27	-48.9 Units on a scale Standard Deviation 36.63	-40.1 Units on a scale Standard Deviation 35.87	-13.3 Units on a scale Standard Deviation 30.13	-32.2 Units on a scale Standard Deviation 32.39
Change From Baseline in SALT Score at Week 28, 34, 40, and 48 Baseline	94.4 Units on a scale Standard Deviation 9.31	90.3 Units on a scale Standard Deviation 15.05	90.5 Units on a scale Standard Deviation 14.28	90.3 Units on a scale Standard Deviation 14.69	90.0 Units on a scale Standard Deviation 15.07	88.3 Units on a scale Standard Deviation 16.87	91.5 Units on a scale Standard Deviation 13.22
Change From Baseline in SALT Score at Week 28, 34, 40, and 48 Change at Week 34	-27.5 Units on a scale Standard Deviation 32.78	-48.2 Units on a scale Standard Deviation 36.16	-35.5 Units on a scale Standard Deviation 35.50	-43.6 Units on a scale Standard Deviation 34.35	-33.5 Units on a scale Standard Deviation 35.01	-7.6 Units on a scale Standard Deviation 23.61	-12.6 Units on a scale Standard Deviation 24.47

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 24	3.64 Percentage of participants Interval 0.0 to 8.58	33.98 Percentage of participants Interval 24.83 to 43.13	25.49 Percentage of participants Interval 17.03 to 33.95	29.00 Percentage of participants Interval 20.11 to 37.89	16.67 Percentage of participants Interval 9.43 to 23.9	8.33 Percentage of participants Interval 0.51 to 16.15	5.77 Percentage of participants Interval 0.0 to 12.11
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 8	3.77 Percentage of participants Interval 0.0 to 8.9	10.28 Percentage of participants Interval 4.53 to 16.03	13.86 Percentage of participants Interval 7.12 to 20.6	2.97 Percentage of participants Interval 0.0 to 6.28	4.90 Percentage of participants Interval 0.71 to 9.09	3.85 Percentage of participants Interval 0.0 to 9.07	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 12	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.	22.86 Percentage of participants Interval 14.83 to 30.89	17.48 Percentage of participants Interval 10.14 to 24.81	9.62 Percentage of participants Interval 3.95 to 15.28	7.62 Percentage of participants Interval 2.54 to 12.69	6.25 Percentage of participants Interval 0.0 to 13.1	4.00 Percentage of participants Interval 0.0 to 9.43
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 18	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.	29.70 Percentage of participants Interval 20.79 to 38.61	18.81 Percentage of participants Interval 11.19 to 26.43	17.82 Percentage of participants Interval 10.36 to 25.29	12.87 Percentage of participants Interval 6.34 to 19.4	10.20 Percentage of participants Interval 1.73 to 18.68	8.16 Percentage of participants Interval 0.5 to 15.83
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 28	4.17 Percentage of participants Interval 0.0 to 9.82	37.00 Percentage of participants Interval 27.54 to 46.46	29.00 Percentage of participants Interval 20.11 to 37.89	27.27 Percentage of participants Interval 18.5 to 36.05	24.76 Percentage of participants Interval 16.51 to 33.02	12.24 Percentage of participants Interval 3.07 to 21.42	6.00 Percentage of participants Interval 0.0 to 12.58
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 34	15.69 Percentage of participants Interval 5.71 to 25.67	41.35 Percentage of participants Interval 31.88 to 50.81	30.77 Percentage of participants Interval 21.9 to 39.64	34.65 Percentage of participants Interval 25.37 to 43.93	31.43 Percentage of participants Interval 22.55 to 40.31	14.58 Percentage of participants Interval 4.6 to 24.57	13.46 Percentage of participants Interval 4.18 to 22.74
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 40	20.00 Percentage of participants Interval 9.43 to 30.57	43.40 Percentage of participants Interval 33.96 to 52.83	30.39 Percentage of participants Interval 21.47 to 39.32	39.00 Percentage of participants Interval 29.44 to 48.56	33.65 Percentage of participants Interval 24.57 to 42.74	16.00 Percentage of participants Interval 5.84 to 26.16	26.92 Percentage of participants Interval 14.87 to 38.98
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 48	30.91 Percentage of participants Interval 18.7 to 43.12	42.99 Percentage of participants Interval 33.61 to 52.37	32.67 Percentage of participants Interval 23.53 to 41.82	43.56 Percentage of participants Interval 33.89 to 53.23	33.33 Percentage of participants Interval 24.32 to 42.35	16.00 Percentage of participants Interval 5.84 to 26.16	31.37 Percentage of participants Interval 18.64 to 44.11
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 4	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.	1.87 Percentage of participants Interval 0.0 to 4.44	2.88 Percentage of participants Interval 0.0 to 6.1	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.	0.93 Percentage of participants Interval 0.0 to 2.76	1.96 Percentage of participants Interval 0.0 to 5.77	3.85 Percentage of participants Interval 0.0 to 9.07

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 4	2.04 Percentage of participants Interval 0.0 to 6.0	3.03 Percentage of participants Interval 0.0 to 6.41	1.08 Percentage of participants Interval 0.0 to 3.17	5.38 Percentage of participants Interval 0.79 to 9.96	1.03 Percentage of participants Interval 0.0 to 3.04	4.55 Percentage of participants Interval 0.0 to 10.7	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 8	2.04 Percentage of participants Interval 0.0 to 6.0	9.09 Percentage of participants Interval 3.43 to 14.75	4.44 Percentage of participants Interval 0.19 to 8.7	8.79 Percentage of participants Interval 2.97 to 14.61	4.35 Percentage of participants Interval 0.18 to 8.51	2.22 Percentage of participants Interval 0.0 to 6.53	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 12	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.	16.49 Percentage of participants Interval 9.11 to 23.88	10.99 Percentage of participants Interval 4.56 to 17.41	11.70 Percentage of participants Interval 5.2 to 18.2	7.37 Percentage of participants Interval 2.11 to 12.62	4.76 Percentage of participants Interval 0.0 to 11.2	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 18	2.17 Percentage of participants Interval 0.0 to 6.39	25.53 Percentage of participants Interval 16.72 to 34.35	20.00 Percentage of participants Interval 11.74 to 28.26	20.00 Percentage of participants Interval 11.74 to 28.26	12.09 Percentage of participants Interval 5.39 to 18.79	6.98 Percentage of participants Interval 0.0 to 14.59	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 24	9.80 Percentage of participants Interval 1.64 to 17.97	30.21 Percentage of participants Interval 21.02 to 39.39	21.35 Percentage of participants Interval 12.84 to 29.86	28.89 Percentage of participants Interval 19.52 to 38.25	26.09 Percentage of participants Interval 17.11 to 35.06	4.88 Percentage of participants Interval 0.0 to 11.47	0.00 Percentage of participants 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 28	6.82 Percentage of participants Interval 0.0 to 14.27	29.79 Percentage of participants Interval 20.54 to 39.03	25.00 Percentage of participants Interval 15.95 to 34.05	36.78 Percentage of participants Interval 26.65 to 46.91	24.21 Percentage of participants Interval 15.6 to 32.82	4.76 Percentage of participants Interval 0.0 to 11.2	4.55 Percentage of participants Interval 0.0 to 10.7
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 34	16.67 Percentage of participants Interval 6.12 to 27.21	34.02 Percentage of participants Interval 24.59 to 43.45	26.37 Percentage of participants Interval 17.32 to 35.43	38.89 Percentage of participants Interval 28.82 to 48.96	26.32 Percentage of participants Interval 17.46 to 35.17	7.32 Percentage of participants Interval 0.0 to 15.29	6.52 Percentage of participants Interval 0.0 to 13.66
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 40	25.49 Percentage of participants Interval 13.53 to 37.45	39.80 Percentage of participants Interval 30.1 to 49.49	28.09 Percentage of participants Interval 18.75 to 37.43	38.20 Percentage of participants Interval 28.11 to 48.3	27.66 Percentage of participants Interval 18.62 to 36.7	18.60 Percentage of participants Interval 6.97 to 30.24	17.39 Percentage of participants Interval 6.44 to 28.34
Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 Week 48	37.25 Percentage of participants Interval 23.99 to 50.52	38.38 Percentage of participants Interval 28.8 to 47.96	29.55 Percentage of participants Interval 20.01 to 39.08	40.00 Percentage of participants Interval 29.88 to 50.12	30.53 Percentage of participants Interval 21.27 to 39.79	20.93 Percentage of participants Interval 8.77 to 33.09	35.56 Percentage of participants Interval 21.57 to 49.54

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 24, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: moderately improved	1.59 Percentage of participants	3.10 Percentage of participants	11.29 Percentage of participants	4.72 Percentage of participants	7.87 Percentage of participants	1.61 Percentage of participants	1.54 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: greatly improved	1.59 Percentage of participants	17.19 Percentage of participants	14.88 Percentage of participants	8.13 Percentage of participants	4.13 Percentage of participants	1.64 Percentage of participants	1.56 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: moderately improved	3.17 Percentage of participants	13.28 Percentage of participants	21.49 Percentage of participants	7.32 Percentage of participants	16.53 Percentage of participants	4.92 Percentage of participants	4.69 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: greatly improved	0 Percentage of participants	22.83 Percentage of participants	22.58 Percentage of participants	13.60 Percentage of participants	12.20 Percentage of participants	3.39 Percentage of participants	3.17 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: moderately improved	10.00 Percentage of participants	18.11 Percentage of participants	19.35 Percentage of participants	14.40 Percentage of participants	14.63 Percentage of participants	3.39 Percentage of participants	7.94 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: greatly improved	1.67 Percentage of participants	27.64 Percentage of participants	22.31 Percentage of participants	18.03 Percentage of participants	19.33 Percentage of participants	1.64 Percentage of participants	3.28 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: moderately improved	10.00 Percentage of participants	23.58 Percentage of participants	23.97 Percentage of participants	27.87 Percentage of participants	15.13 Percentage of participants	6.56 Percentage of participants	4.92 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: greatly improved	1.54 Percentage of participants	36.51 Percentage of participants	26.45 Percentage of participants	28.80 Percentage of participants	28.93 Percentage of participants	1.67 Percentage of participants	4.62 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: moderately improved	9.23 Percentage of participants	16.67 Percentage of participants	20.66 Percentage of participants	20.80 Percentage of participants	13.22 Percentage of participants	10.00 Percentage of participants	3.08 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: greatly improved	18.64 Percentage of participants	43.20 Percentage of participants	35.54 Percentage of participants	37.40 Percentage of participants	31.97 Percentage of participants	5.08 Percentage of participants	7.81 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: moderately improved	22.03 Percentage of participants	12.00 Percentage of participants	17.36 Percentage of participants	15.45 Percentage of participants	15.57 Percentage of participants	6.78 Percentage of participants	20.31 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: greatly improved	30.77 Percentage of participants	43.75 Percentage of participants	34.68 Percentage of participants	37.70 Percentage of participants	30.00 Percentage of participants	6.78 Percentage of participants	13.85 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: moderately improved	24.62 Percentage of participants	15.63 Percentage of participants	14.52 Percentage of participants	14.75 Percentage of participants	19.17 Percentage of participants	11.86 Percentage of participants	15.38 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: greatly improved	42.19 Percentage of participants	44.96 Percentage of participants	33.33 Percentage of participants	42.40 Percentage of participants	31.15 Percentage of participants	6.56 Percentage of participants	26.56 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: moderately improved	17.19 Percentage of participants	13.18 Percentage of participants	18.70 Percentage of participants	13.60 Percentage of participants	18.03 Percentage of participants	9.84 Percentage of participants	17.19 Percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: greatly improved	0 Percentage of participants	5.43 Percentage of participants	4.03 Percentage of participants	2.36 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 8, 12, 18, and 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.

AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 12: emotional symptoms	-0.36 Units on a scale Interval -0.49 to -0.23	-0.53 Units on a scale Interval -0.66 to -0.4	-0.54 Units on a scale Interval -0.67 to -0.41	-0.48 Units on a scale Interval -0.61 to -0.34	-0.49 Units on a scale Interval -0.63 to -0.36	-0.50 Units on a scale Interval -0.69 to -0.31	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 18: emotional symptoms	-0.43 Units on a scale Interval -0.56 to -0.29	-0.64 Units on a scale Interval -0.78 to -0.51	-0.57 Units on a scale Interval -0.71 to -0.44	-0.60 Units on a scale Interval -0.74 to -0.46	-0.54 Units on a scale Interval -0.68 to -0.4	-0.44 Units on a scale Interval -0.63 to -0.24	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 24: emotional symptoms	-0.47 Units on a scale Interval -0.61 to -0.33	-0.61 Units on a scale Interval -0.75 to -0.46	-0.61 Units on a scale Interval -0.76 to -0.47	-0.69 Units on a scale Interval -0.83 to -0.54	-0.58 Units on a scale Interval -0.72 to -0.43	-0.49 Units on a scale Interval -0.7 to -0.28	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 4: activity limitations	-0.18 Units on a scale Interval -0.29 to -0.07	-0.19 Units on a scale Interval -0.29 to -0.08	-0.04 Units on a scale Interval -0.15 to 0.07	-0.16 Units on a scale Interval -0.27 to -0.05	-0.13 Units on a scale Interval -0.24 to -0.02	-0.20 Units on a scale Interval -0.36 to -0.04	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 8: activity limitations	-0.20 Units on a scale Interval -0.31 to -0.09	-0.24 Units on a scale Interval -0.34 to -0.13	-0.25 Units on a scale Interval -0.36 to -0.14	-0.18 Units on a scale Interval -0.29 to -0.07	-0.09 Units on a scale Interval -0.2 to 0.02	-0.21 Units on a scale Interval -0.37 to -0.05	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 12: activity limitations	-0.21 Units on a scale Interval -0.32 to -0.11	-0.27 Units on a scale Interval -0.38 to -0.17	-0.22 Units on a scale Interval -0.32 to -0.11	-0.21 Units on a scale Interval -0.32 to -0.11	-0.24 Units on a scale Interval -0.35 to -0.13	-0.27 Units on a scale Interval -0.42 to -0.11	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 18: activity limitations	-0.26 Units on a scale Interval -0.36 to -0.15	-0.35 Units on a scale Interval -0.45 to -0.24	-0.26 Units on a scale Interval -0.36 to -0.15	-0.23 Units on a scale Interval -0.34 to -0.12	-0.23 Units on a scale Interval -0.34 to -0.12	-0.28 Units on a scale Interval -0.44 to -0.13	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 24: activity limitations	-0.29 Units on a scale Interval -0.39 to -0.19	-0.30 Units on a scale Interval -0.4 to -0.2	-0.30 Units on a scale Interval -0.4 to -0.2	-0.31 Units on a scale Interval -0.41 to -0.21	-0.28 Units on a scale Interval -0.38 to -0.18	-0.31 Units on a scale Interval -0.45 to -0.16	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 4: emotional symptoms	-0.28 Units on a scale Interval -0.4 to -0.16	-0.37 Units on a scale Interval -0.49 to -0.25	-0.22 Units on a scale Interval -0.34 to -0.1	-0.33 Units on a scale Interval -0.45 to -0.21	-0.31 Units on a scale Interval -0.44 to -0.19	-0.29 Units on a scale Interval -0.47 to -0.11	—
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations Change at Week 8: emotional symptoms	-0.39 Units on a scale Interval -0.51 to -0.27	-0.50 Units on a scale Interval -0.62 to -0.38	-0.46 Units on a scale Interval -0.58 to -0.34	-0.50 Units on a scale Interval -0.62 to -0.37	-0.36 Units on a scale Interval -0.48 to -0.23	-0.45 Units on a scale Interval -0.62 to -0.27	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 34: emotional symptoms	-0.77 Units on a scale Standard Deviation 0.92	-0.78 Units on a scale Standard Deviation 0.95	-0.72 Units on a scale Standard Deviation 1.00	-0.72 Units on a scale Standard Deviation 0.93	-0.71 Units on a scale Standard Deviation 1.06	-0.62 Units on a scale Standard Deviation 0.83	-0.64 Units on a scale Standard Deviation 0.91
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 40: emotional symptoms	-0.83 Units on a scale Standard Deviation 1.01	-0.84 Units on a scale Standard Deviation 1.04	-0.80 Units on a scale Standard Deviation 1.02	-0.81 Units on a scale Standard Deviation 0.98	-0.83 Units on a scale Standard Deviation 1.11	-0.62 Units on a scale Standard Deviation 0.96	-0.66 Units on a scale Standard Deviation 1.00
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 48: emotional symptoms	-0.98 Units on a scale Standard Deviation 1.05	-0.96 Units on a scale Standard Deviation 0.99	-0.84 Units on a scale Standard Deviation 1.07	-0.85 Units on a scale Standard Deviation 1.04	-0.72 Units on a scale Standard Deviation 1.15	-0.50 Units on a scale Standard Deviation 0.89	-0.68 Units on a scale Standard Deviation 1.03
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 34: activity limitations	-0.36 Units on a scale Standard Deviation 0.59	-0.37 Units on a scale Standard Deviation 0.71	-0.31 Units on a scale Standard Deviation 0.78	-0.26 Units on a scale Standard Deviation 0.73	-0.37 Units on a scale Standard Deviation 0.78	-0.33 Units on a scale Standard Deviation 0.76	-0.42 Units on a scale Standard Deviation 0.78
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 40: activity limitations	-0.40 Units on a scale Standard Deviation 0.66	-0.44 Units on a scale Standard Deviation 0.76	-0.33 Units on a scale Standard Deviation 0.84	-0.25 Units on a scale Standard Deviation 0.68	-0.42 Units on a scale Standard Deviation 0.81	-0.23 Units on a scale Standard Deviation 0.71	-0.39 Units on a scale Standard Deviation 0.84
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations Change at Week 48: activity limitations	-0.44 Units on a scale Standard Deviation 0.71	-0.43 Units on a scale Standard Deviation 0.79	-0.39 Units on a scale Standard Deviation 0.84	-0.29 Units on a scale Standard Deviation 0.76	-0.36 Units on a scale Standard Deviation 0.85	-0.26 Units on a scale Standard Deviation 0.90	-0.36 Units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Week 4, 8, 12, 18, 24, 34, 40, and 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.

AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: current hair loss on scalp	8.33 Percentage of participants Interval 1.34 to 15.33	27.35 Percentage of participants Interval 19.27 to 35.43	25.00 Percentage of participants Interval 17.25 to 32.75	13.79 Percentage of participants Interval 7.52 to 20.07	16.38 Percentage of participants Interval 9.64 to 23.11	8.62 Percentage of participants Interval 1.4 to 15.84	6.78 Percentage of participants Interval 0.36 to 13.19
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: current hair loss on scalp	10.77 Percentage of participants Interval 3.23 to 18.31	35.83 Percentage of participants Interval 27.25 to 44.41	30.00 Percentage of participants Interval 21.8 to 38.2	26.27 Percentage of participants Interval 18.33 to 34.21	24.58 Percentage of participants Interval 16.81 to 32.34	5.26 Percentage of participants Interval 0.0 to 11.06	6.35 Percentage of participants Interval 0.33 to 12.37
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: current hair loss on scalp	22.03 Percentage of participants Interval 11.46 to 32.61	42.02 Percentage of participants Interval 33.15 to 50.89	34.45 Percentage of participants Interval 25.92 to 42.99	29.31 Percentage of participants Interval 21.03 to 37.59	30.25 Percentage of participants Interval 22.0 to 38.51	7.14 Percentage of participants Interval 0.4 to 13.89	11.29 Percentage of participants Interval 3.41 to 19.17
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: current hair loss on scalp	29.23 Percentage of participants Interval 18.17 to 40.29	41.80 Percentage of participants Interval 33.05 to 50.56	36.59 Percentage of participants Interval 28.07 to 45.1	35.65 Percentage of participants Interval 26.9 to 44.41	32.48 Percentage of participants Interval 23.99 to 40.96	8.93 Percentage of participants Interval 1.46 to 16.4	19.05 Percentage of participants Interval 9.35 to 28.74
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: current hair loss on eyebrows	11.11 Percentage of participants Interval 1.93 to 20.29	27.66 Percentage of participants Interval 18.62 to 36.7	33.68 Percentage of participants Interval 24.18 to 43.19	27.47 Percentage of participants Interval 18.3 to 36.64	19.78 Percentage of participants Interval 11.6 to 27.96	13.33 Percentage of participants Interval 3.4 to 23.27	7.14 Percentage of participants Interval 0.0 to 14.93
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: current hair loss on eyebrows	12.00 Percentage of participants Interval 2.99 to 21.01	32.29 Percentage of participants Interval 22.94 to 41.65	32.98 Percentage of participants Interval 23.47 to 42.48	30.43 Percentage of participants Interval 21.03 to 39.84	29.35 Percentage of participants Interval 20.04 to 38.65	6.82 Percentage of participants Interval 0.0 to 14.27	10.87 Percentage of participants Interval 1.87 to 19.86
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: current hair loss on eyebrows	32.00 Percentage of participants Interval 19.07 to 44.93	42.27 Percentage of participants Interval 32.44 to 52.1	36.84 Percentage of participants Interval 27.14 to 46.54	38.89 Percentage of participants Interval 28.82 to 48.96	38.04 Percentage of participants Interval 28.12 to 47.96	20.00 Percentage of participants Interval 8.31 to 31.69	23.91 Percentage of participants Interval 11.59 to 36.24
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: current hair loss on eyebrows	38.00 Percentage of participants Interval 24.55 to 51.45	44.90 Percentage of participants Interval 35.05 to 54.75	34.04 Percentage of participants Interval 24.46 to 43.62	43.96 Percentage of participants Interval 33.76 to 54.15	39.36 Percentage of participants Interval 29.49 to 49.24	15.56 Percentage of participants Interval 4.97 to 26.14	33.33 Percentage of participants Interval 19.56 to 47.11
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: current hair loss on eyelashes	14.63 Percentage of participants Interval 3.82 to 25.45	29.41 Percentage of participants Interval 19.73 to 39.1	26.74 Percentage of participants Interval 17.39 to 36.1	16.46 Percentage of participants Interval 8.28 to 24.63	19.05 Percentage of participants Interval 10.65 to 27.44	8.33 Percentage of participants Interval 0.0 to 17.36	8.33 Percentage of participants Interval 0.0 to 17.36
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: current hair loss on eyelashes	12.20 Percentage of participants Interval 2.18 to 22.21	31.33 Percentage of participants Interval 21.35 to 41.3	37.65 Percentage of participants Interval 27.35 to 47.95	21.05 Percentage of participants Interval 11.89 to 30.22	22.22 Percentage of participants Interval 13.17 to 31.28	7.89 Percentage of participants Interval 0.0 to 16.47	2.94 Percentage of participants Interval 0.0 to 8.62
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: current hair loss on eyelashes	13.04 Percentage of participants Interval 3.31 to 22.78	31.40 Percentage of participants Interval 21.59 to 41.2	42.17 Percentage of participants Interval 31.54 to 52.79	31.17 Percentage of participants Interval 20.82 to 41.51	28.05 Percentage of participants Interval 18.33 to 37.77	8.33 Percentage of participants Interval 0.0 to 17.36	2.63 Percentage of participants Interval 0.0 to 7.72
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: current hair loss on eyelashes	21.43 Percentage of participants Interval 9.02 to 33.84	40.00 Percentage of participants Interval 29.59 to 50.41	36.59 Percentage of participants Interval 26.16 to 47.01	37.33 Percentage of participants Interval 26.39 to 48.28	34.52 Percentage of participants Interval 24.36 to 44.69	11.43 Percentage of participants Interval 0.89 to 21.97	13.51 Percentage of participants Interval 2.5 to 24.53
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: current hair loss on body	4.26 Percentage of participants Interval 0.0 to 10.03	11.46 Percentage of participants Interval 5.09 to 17.83	9.28 Percentage of participants Interval 3.5 to 15.05	10.42 Percentage of participants Interval 4.31 to 16.53	6.38 Percentage of participants Interval 1.44 to 11.32	2.13 Percentage of participants Interval 0.0 to 6.25	11.36 Percentage of participants Interval 1.99 to 20.74
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 24: current hair loss on body	16.33 Percentage of participants Interval 5.98 to 26.68	25.81 Percentage of participants Interval 16.91 to 34.7	27.96 Percentage of participants Interval 18.84 to 37.08	20.43 Percentage of participants Interval 12.24 to 28.62	22.22 Percentage of participants Interval 13.63 to 30.81	6.67 Percentage of participants Interval 0.0 to 13.95	11.36 Percentage of participants Interval 1.99 to 20.74
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: current hair loss on eyebrows	22.73 Percentage of participants Interval 10.34 to 35.11	42.71 Percentage of participants Interval 32.81 to 52.6	38.71 Percentage of participants Interval 28.81 to 48.61	38.89 Percentage of participants Interval 28.82 to 48.96	31.91 Percentage of participants Interval 22.49 to 41.34	16.28 Percentage of participants Interval 5.24 to 27.31	13.33 Percentage of participants Interval 3.4 to 23.27
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: current hair loss on eyelashes	8.89 Percentage of participants Interval 0.57 to 17.2	11.49 Percentage of participants Interval 4.79 to 18.2	4.60 Percentage of participants Interval 0.2 to 9.0	7.59 Percentage of participants Interval 1.75 to 13.44	9.30 Percentage of participants Interval 3.16 to 15.44	5.26 Percentage of participants Interval 0.0 to 12.36	5.26 Percentage of participants Interval 0.0 to 12.36
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: current hair loss on eyelashes	6.67 Percentage of participants Interval 0.0 to 13.95	17.44 Percentage of participants Interval 9.42 to 25.46	17.65 Percentage of participants Interval 9.54 to 25.75	12.82 Percentage of participants Interval 5.4 to 20.24	14.81 Percentage of participants Interval 7.08 to 22.55	7.89 Percentage of participants Interval 0.0 to 16.47	8.11 Percentage of participants Interval 0.0 to 16.9
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: current hair loss on eyelashes	28.26 Percentage of participants Interval 15.25 to 41.27	43.02 Percentage of participants Interval 32.56 to 53.49	39.29 Percentage of participants Interval 28.84 to 49.73	32.89 Percentage of participants Interval 22.33 to 43.46	36.59 Percentage of participants Interval 26.16 to 47.01	10.81 Percentage of participants Interval 0.81 to 20.82	13.16 Percentage of participants Interval 2.41 to 23.91
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: current hair loss on eyelashes	39.13 Percentage of participants Interval 25.03 to 53.23	41.86 Percentage of participants Interval 31.43 to 52.29	37.35 Percentage of participants Interval 26.94 to 47.76	38.16 Percentage of participants Interval 27.24 to 49.08	34.52 Percentage of participants Interval 24.36 to 44.69	8.11 Percentage of participants Interval 0.0 to 16.9	28.95 Percentage of participants Interval 14.53 to 43.37
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: current hair loss on body	6.38 Percentage of participants Interval 0.0 to 13.37	14.74 Percentage of participants Interval 7.61 to 21.86	15.96 Percentage of participants Interval 8.55 to 23.36	13.98 Percentage of participants Interval 6.93 to 21.03	10.11 Percentage of participants Interval 3.85 to 16.38	2.17 Percentage of participants Interval 0.0 to 6.39	11.63 Percentage of participants Interval 2.05 to 21.21
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: current hair loss on body	11.36 Percentage of participants Interval 1.99 to 20.74	17.02 Percentage of participants Interval 9.42 to 24.62	19.15 Percentage of participants Interval 11.19 to 27.1	14.89 Percentage of participants Interval 7.7 to 22.09	14.29 Percentage of participants Interval 7.1 to 21.48	4.44 Percentage of participants Interval 0.0 to 10.47	7.14 Percentage of participants Interval 0.0 to 14.93
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 18: current hair loss on body	9.09 Percentage of participants Interval 0.6 to 17.59	19.78 Percentage of participants Interval 11.6 to 27.96	25.00 Percentage of participants Interval 16.15 to 33.85	15.05 Percentage of participants Interval 7.79 to 22.32	15.91 Percentage of participants Interval 8.27 to 23.55	10.64 Percentage of participants Interval 1.82 to 19.45	7.50 Percentage of participants Interval 0.0 to 15.66
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 34: current hair loss on body	22.73 Percentage of participants Interval 10.34 to 35.11	33.33 Percentage of participants Interval 23.75 to 42.91	33.70 Percentage of participants Interval 24.04 to 43.35	31.52 Percentage of participants Interval 22.03 to 41.02	26.09 Percentage of participants Interval 17.11 to 35.06	11.36 Percentage of participants Interval 1.99 to 20.74	9.30 Percentage of participants Interval 0.62 to 17.98
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 40: current hair loss on body	22.45 Percentage of participants Interval 10.77 to 34.13	35.11 Percentage of participants Interval 25.46 to 44.76	36.17 Percentage of participants Interval 26.46 to 45.88	30.77 Percentage of participants Interval 21.29 to 40.25	25.56 Percentage of participants Interval 16.54 to 34.57	8.70 Percentage of participants Interval 0.55 to 16.84	11.36 Percentage of participants Interval 1.99 to 20.74
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: current hair loss on body	34.69 Percentage of participants Interval 21.37 to 48.02	34.74 Percentage of participants Interval 25.16 to 44.31	34.41 Percentage of participants Interval 24.75 to 44.06	36.56 Percentage of participants Interval 26.77 to 46.35	30.43 Percentage of participants Interval 21.03 to 39.84	10.87 Percentage of participants Interval 1.87 to 19.86	20.45 Percentage of participants Interval 8.54 to 32.37
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: current hair loss on scalp	6.35 Percentage of participants Interval 0.33 to 12.37	11.38 Percentage of participants Interval 5.77 to 16.99	9.76 Percentage of participants Interval 4.51 to 15.0	4.17 Percentage of participants Interval 0.59 to 7.74	4.84 Percentage of participants Interval 1.06 to 8.62	1.69 Percentage of participants Interval 0.0 to 4.99	3.17 Percentage of participants Interval 0.0 to 7.5
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: current hair loss on scalp	4.76 Percentage of participants Interval 0.0 to 10.02	11.48 Percentage of participants Interval 5.82 to 17.13	16.67 Percentage of participants Interval 10.0 to 23.33	7.76 Percentage of participants Interval 2.89 to 12.63	8.47 Percentage of participants Interval 3.45 to 13.5	1.72 Percentage of participants Interval 0.0 to 5.07	8.06 Percentage of participants Interval 1.29 to 14.84
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: current hair loss on scalp	6.67 Percentage of participants Interval 0.35 to 12.98	20.66 Percentage of participants Interval 13.45 to 27.88	19.51 Percentage of participants Interval 12.51 to 26.52	12.71 Percentage of participants Interval 6.7 to 18.72	13.33 Percentage of participants Interval 7.25 to 19.42	3.57 Percentage of participants Interval 0.0 to 8.43	4.92 Percentage of participants Interval 0.0 to 10.34
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 48: current hair loss on scalp	33.85 Percentage of participants Interval 22.34 to 45.35	42.28 Percentage of participants Interval 33.55 to 51.01	33.61 Percentage of participants Interval 25.22 to 41.99	42.37 Percentage of participants Interval 33.46 to 51.29	32.77 Percentage of participants Interval 24.34 to 41.21	8.62 Percentage of participants Interval 1.4 to 15.84	20.97 Percentage of participants Interval 10.83 to 31.1
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 4: current hair loss on eyebrows	6.25 Percentage of participants Interval 0.0 to 13.1	9.09 Percentage of participants Interval 3.43 to 14.75	7.14 Percentage of participants Interval 2.04 to 12.24	7.45 Percentage of participants Interval 2.14 to 12.75	4.17 Percentage of participants Interval 0.17 to 8.16	4.35 Percentage of participants Interval 0.0 to 10.24	8.70 Percentage of participants Interval 0.55 to 16.84
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 8: current hair loss on eyebrows	4.17 Percentage of participants Interval 0.0 to 9.82	17.35 Percentage of participants Interval 9.85 to 24.84	21.05 Percentage of participants Interval 12.85 to 29.25	11.96 Percentage of participants Interval 5.33 to 18.59	10.99 Percentage of participants Interval 4.56 to 17.41	6.52 Percentage of participants Interval 0.0 to 13.66	11.11 Percentage of participants Interval 1.93 to 20.29
Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 Week 12: current hair loss on eyebrows	11.11 Percentage of participants Interval 1.93 to 20.29	27.84 Percentage of participants Interval 18.92 to 36.75	27.84 Percentage of participants Interval 18.92 to 36.75	18.09 Percentage of participants Interval 10.3 to 25.87	15.96 Percentage of participants Interval 8.55 to 23.36	11.63 Percentage of participants Interval 2.05 to 21.21	6.82 Percentage of participants Interval 0.0 to 14.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 4, 8, 12, and 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 4	-0.3 Units on a scale Interval -0.73 to 0.07	-0.1 Units on a scale Interval -0.54 to 0.26	-0.4 Units on a scale Interval -0.82 to -0.01	-0.1 Units on a scale Interval -0.48 to 0.33	-0.1 Units on a scale Interval -0.48 to 0.33	-0.3 Units on a scale Interval -0.86 to 0.32	—
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 8	-0.3 Units on a scale Interval -0.73 to 0.1	-0.5 Units on a scale Interval -0.89 to -0.06	-0.3 Units on a scale Interval -0.71 to 0.12	-0.2 Units on a scale Interval -0.58 to 0.26	0.2 Units on a scale Interval -0.25 to 0.59	-0.2 Units on a scale Interval -0.79 to 0.43	—
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 12	-0.1 Units on a scale Interval -0.53 to 0.3	-0.6 Units on a scale Interval -1.04 to -0.21	-0.4 Units on a scale Interval -0.81 to 0.03	0.0 Units on a scale Interval -0.45 to 0.39	0.1 Units on a scale Interval -0.32 to 0.53	-0.5 Units on a scale Interval -1.07 to 0.15	—
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 24	0.0 Units on a scale Interval -0.46 to 0.39	-0.4 Units on a scale Interval -0.79 to 0.07	-0.8 Units on a scale Interval -1.21 to -0.35	-0.3 Units on a scale Interval -0.7 to 0.16	-0.2 Units on a scale Interval -0.66 to 0.21	-0.4 Units on a scale Interval -1.04 to 0.21	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 48

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 Baseline	3.2 Units on a scale Standard Deviation 3.36	2.7 Units on a scale Standard Deviation 2.60	3.0 Units on a scale Standard Deviation 3.16	2.9 Units on a scale Standard Deviation 3.00	2.8 Units on a scale Standard Deviation 2.99	2.8 Units on a scale Standard Deviation 2.80	3.3 Units on a scale Standard Deviation 3.54
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 Change at Week 48	-0.9 Units on a scale Standard Deviation 3.25	-0.7 Units on a scale Standard Deviation 2.13	-0.4 Units on a scale Standard Deviation 3.15	-0.3 Units on a scale Standard Deviation 2.67	-0.6 Units on a scale Standard Deviation 2.44	-0.5 Units on a scale Standard Deviation 2.53	-0.4 Units on a scale Standard Deviation 3.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 4, 8, 12, and 24

Population: FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 4	-0.1 Units on a scale Interval -0.54 to 0.32	-0.3 Units on a scale Interval -0.78 to 0.08	-0.4 Units on a scale Interval -0.79 to 0.08	-0.4 Units on a scale Interval -0.79 to 0.08	-0.5 Units on a scale Interval -0.97 to -0.1	-0.6 Units on a scale Interval -1.25 to 0.02	—
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 8	-0.5 Units on a scale Interval -0.96 to -0.03	-0.8 Units on a scale Interval -1.25 to -0.31	-0.4 Units on a scale Interval -0.88 to 0.07	-0.8 Units on a scale Interval -1.27 to -0.31	-0.3 Units on a scale Interval -0.79 to 0.17	-0.9 Units on a scale Interval -1.59 to -0.2	—
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 12	-0.4 Units on a scale Interval -0.84 to 0.09	-0.7 Units on a scale Interval -1.22 to -0.28	-0.9 Units on a scale Interval -1.4 to -0.46	-0.7 Units on a scale Interval -1.22 to -0.27	-0.3 Units on a scale Interval -0.77 to 0.19	-0.9 Units on a scale Interval -1.55 to -0.17	—
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 Change at Week 24	-0.6 Units on a scale Interval -1.06 to -0.07	-0.8 Units on a scale Interval -1.26 to -0.25	-0.7 Units on a scale Interval -1.19 to -0.18	-0.8 Units on a scale Interval -1.28 to -0.27	-0.3 Units on a scale Interval -0.76 to 0.26	-1.0 Units on a scale Interval -1.69 to -0.21	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 48

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=131 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=63 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 Baseline	5.3 Units on a scale Standard Deviation 4.20	4.6 Units on a scale Standard Deviation 3.84	4.5 Units on a scale Standard Deviation 3.18	4.9 Units on a scale Standard Deviation 3.31	4.3 Units on a scale Standard Deviation 3.42	5.2 Units on a scale Standard Deviation 3.38	5.3 Units on a scale Standard Deviation 3.70
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 Change at Week 48	-1.3 Units on a scale Standard Deviation 3.31	-1.0 Units on a scale Standard Deviation 2.92	-0.8 Units on a scale Standard Deviation 3.10	-0.8 Units on a scale Standard Deviation 3.09	-0.5 Units on a scale Standard Deviation 3.40	-1.2 Units on a scale Standard Deviation 2.89	-0.5 Units on a scale Standard Deviation 4.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4, 8, 12, 24 and 48

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=5 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=7 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=11 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=13 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=14 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=5 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=10 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 12	60.00 Percentage of participants Interval 17.06 to 100.0	50.00 Percentage of participants Interval 9.99 to 90.01	63.64 Percentage of participants Interval 35.21 to 92.06	66.67 Percentage of participants Interval 39.99 to 93.34	30.77 Percentage of participants Interval 5.68 to 55.86	20.00 Percentage of participants Interval 0.0 to 55.06	62.50 Percentage of participants Interval 28.95 to 96.05
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 24	50.00 Percentage of participants Interval 1.0 to 99.0	71.43 Percentage of participants Interval 37.96 to 100.0	63.64 Percentage of participants Interval 35.21 to 92.06	41.67 Percentage of participants Interval 13.77 to 69.56	42.86 Percentage of participants Interval 16.93 to 68.78	50.00 Percentage of participants Interval 1.0 to 99.0	50.00 Percentage of participants Interval 19.01 to 80.99
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 4	60.00 Percentage of participants Interval 17.06 to 100.0	42.86 Percentage of participants Interval 6.2 to 79.52	60.00 Percentage of participants Interval 29.64 to 90.36	53.85 Percentage of participants Interval 26.75 to 80.95	42.86 Percentage of participants Interval 16.93 to 68.78	40.00 Percentage of participants Interval 0.0 to 82.94	50.00 Percentage of participants Interval 19.01 to 80.99
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 8	50.00 Percentage of participants Interval 1.0 to 99.0	66.67 Percentage of participants Interval 28.95 to 100.0	45.45 Percentage of participants Interval 16.03 to 74.88	58.33 Percentage of participants Interval 30.44 to 86.23	33.33 Percentage of participants Interval 6.66 to 60.01	20.00 Percentage of participants Interval 0.0 to 55.06	40.00 Percentage of participants Interval 9.64 to 70.36
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 48	60.00 Percentage of participants Interval 17.06 to 100.0	50.00 Percentage of participants Interval 9.99 to 90.01	63.64 Percentage of participants Interval 35.21 to 92.06	58.33 Percentage of participants Interval 30.44 to 86.23	46.15 Percentage of participants Interval 19.05 to 73.25	80.00 Percentage of participants Interval 44.94 to 100.0	60.00 Percentage of participants Interval 29.64 to 90.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4, 8, 12, 24 and 48

HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.

Outcome measures

Outcome measures
Measure	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=19 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=29 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=22 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=26 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=16 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=15 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=13 Participants Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 4	31.58 Percentage of participants Interval 10.68 to 52.48	51.72 Percentage of participants Interval 33.54 to 69.91	45.45 Percentage of participants Interval 24.65 to 66.26	34.62 Percentage of participants Interval 16.33 to 52.9	37.50 Percentage of participants Interval 13.78 to 61.22	40.00 Percentage of participants Interval 15.21 to 64.79	30.77 Percentage of participants Interval 5.68 to 55.86
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 8	33.33 Percentage of participants Interval 11.56 to 55.11	46.43 Percentage of participants Interval 27.96 to 64.9	50.00 Percentage of participants Interval 28.09 to 71.91	68.00 Percentage of participants Interval 49.71 to 86.29	41.67 Percentage of participants Interval 13.77 to 69.56	71.43 Percentage of participants Interval 47.76 to 95.09	46.15 Percentage of participants Interval 19.05 to 73.25
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 12	47.37 Percentage of participants Interval 24.92 to 69.82	50.00 Percentage of participants Interval 31.48 to 68.52	57.89 Percentage of participants Interval 35.69 to 80.1	38.46 Percentage of participants Interval 19.76 to 57.16	56.25 Percentage of participants Interval 31.94 to 80.56	42.86 Percentage of participants Interval 16.93 to 68.78	41.67 Percentage of participants Interval 13.77 to 69.56
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 24	44.44 Percentage of participants Interval 21.49 to 67.4	51.85 Percentage of participants Interval 33.01 to 70.7	65.00 Percentage of participants Interval 44.1 to 85.9	50.00 Percentage of participants Interval 30.78 to 69.22	46.67 Percentage of participants Interval 21.42 to 71.91	57.14 Percentage of participants Interval 31.22 to 83.07	38.46 Percentage of participants Interval 12.02 to 64.91
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 Week 48	57.89 Percentage of participants Interval 35.69 to 80.1	53.85 Percentage of participants Interval 34.68 to 73.01	66.67 Percentage of participants Interval 44.89 to 88.44	60.00 Percentage of participants Interval 40.8 to 79.2	50.00 Percentage of participants Interval 23.81 to 76.19	61.54 Percentage of participants Interval 35.09 to 87.98	58.33 Percentage of participants Interval 30.44 to 86.23

Adverse Events

Ritlecitinib (PF-06651600) 200 mg Then 50 mg

Serious events: 4 serious events

Other events: 84 other events

Deaths: 0 deaths

Ritlecitinib (PF-06651600) 200 mg Then 30 mg

Serious events: 2 serious events

Other events: 76 other events

Deaths: 0 deaths

Ritlecitinib (PF-06651600) 50 mg

Serious events: 2 serious events

Other events: 81 other events

Deaths: 0 deaths

Ritlecitinib (PF-06651600) 30 mg

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Ritlecitinib (PF-06651600) 10 mg

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo, Ritlecitinib (PF-06651600) 50 mg

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=129 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=62 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Infections and infestations Appendicitis	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.78% 1/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.76% 1/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Empyema	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Sepsis	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Chemical poisoning	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.78% 1/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.77% 1/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Psychiatric disorders Conversion disorder	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Psychiatric disorders Suicidal behaviour	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.78% 1/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.77% 1/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=131 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .	Ritlecitinib (PF-06651600) 200 mg Then 30 mg n=129 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 50 mg n=130 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 30 mg n=132 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Ritlecitinib (PF-06651600) 10 mg n=62 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg n=65 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.	Placebo, Ritlecitinib (PF-06651600) 50 mg n=66 participants at risk Participants aged 12 years or above with moderate to severe AA with \>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.9% 5/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.77% 1/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	5.3% 7/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	6.9% 9/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.1% 4/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.2% 12/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 8/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	8.4% 11/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.1% 12/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.8% 3/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.3% 8/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	4.6% 6/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	5.4% 7/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 2/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.1% 2/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.5% 3/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
General disorders Fatigue	3.1% 4/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.7% 6/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.6% 6/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.5% 6/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.5% 4/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.6% 3/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.0% 2/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Folliculitis	8.4% 11/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	8.5% 11/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 8/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.5% 4/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 4/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Influenza	6.1% 8/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.78% 1/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.8% 3/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	14.5% 19/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	16.3% 21/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	13.8% 18/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	15.9% 21/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	11.3% 7/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	10.8% 7/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 4/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	13.7% 18/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.3% 12/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	8.5% 11/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.1% 16/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.2% 2/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	10.8% 7/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.1% 6/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	8.4% 11/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.77% 1/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.0% 2/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 4/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.9% 5/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 2/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.0% 4/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.2% 2/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.1% 2/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.1% 6/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	4.6% 6/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.7% 6/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Nervous system disorders Dizziness	6.9% 9/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 8/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.1% 4/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 8/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.0% 2/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Nervous system disorders Headache	13.0% 17/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	10.9% 14/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.3% 16/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	18.2% 24/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	19.4% 12/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.3% 8/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.1% 8/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Psychiatric disorders Insomnia	2.3% 3/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 2/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.76% 1/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 4/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	4.6% 6/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.0% 2/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.76% 1/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.78% 1/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 2/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.5% 4/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.1% 4/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.7% 6/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.6% 6/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.76% 1/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.1% 2/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	7.6% 5/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Acne	4.6% 6/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	7.8% 10/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.2% 12/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	9.1% 12/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	4.8% 3/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	7.7% 5/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	12.1% 8/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	3.1% 4/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	5.4% 7/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.77% 1/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	3.8% 5/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	2.3% 3/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	5.4% 7/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.76% 1/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.5% 1/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	6.9% 9/131 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	7.0% 9/129 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	5.4% 7/130 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	3.8% 5/132 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	1.6% 1/62 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.2% 4/65 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.	6.1% 4/66 • Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.

Additional Information

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Results disclosure agreements

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