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NCT07733765

A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

StatusRecruiting
PhasePhase 3
SponsorPfizer
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words
    • Trial sites expanded: 20 → 38 locations
    • Secondary endpoints: details revised at 1 of 47 entries
  2. Trial sites expanded: 17 → 20 locationsv3
  3. Recruitment opened
    • Trial sites expanded: 4 → 17 locations
    • Primary and study completion dates: Apr 27, 2028 to Apr 26, 2028
    • Start date changed from estimate of Jul 31, 2026 to Jul 30, 2026
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Timeframe: Week 24

Secondary (47)

Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus
Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus
Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus
Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus
Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo
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Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period
Proportion of responders for SALT 0 at appliable timepoints after Week 24
Proportion of responders for SALT ≤10 at appliable timepoints after Week 24
Proportion of responders for SALT ≤5 at appliable timepoints after Week 24
Proportion of responders for SALT 75 at appliable timepoints after Week 24
Proportion of responders for SALT 90 at appliable timepoints after Week 24
Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Mean CFB in SALT score at applicable timepoints after Week 24
Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Proportion of responders for EBA at appliable timepoints after Week 24
Proportion of responders for ELA at appliable timepoints after Week 24
Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Proportion of PGI-C responders at applicable timepoints after Week 24
Proportion of P-Sat responders at applicable timepoints after Week 24
Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24
Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24
Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24
Difference in the proportion of PGI-C responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of P-SAT responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected during the safety follow-up period

Arms and interventions

Ritlecitinib 50 milligrams (mg)Experimental

Participants will receive 1 ritlecitinib 50 mg capsule QD orally from Day 1 to Week 24. At Week 24: Responders will be allocated to the below: Arm 1A (Ritlecitinib 50 mg R Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be re-randomized to either of the below: Arm 1B (Ritlecitinib 50 mg NR→50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Arm 1C (Ritlecitinib 50 mg NR→100 mg Group): 1 ritlecitinib 100 mg capsule QD and 1 placebo 50 mg capsule QD orally through Week 48.

PlaceboPlacebo comparator

Participants will receive 1 placebo 50 mg capsule QD orally from Day 1 to Week 24 At Week 24: Responders will be allocated to the below: Arm 2A (Placebo R Group): 1 placebo 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be allocated to the below: Arm 2B (Placebo NR→Ritlecitinib 50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.

Drugs: Ritlecitinib 100 mg, Ritlecitinib 50 mg

Other: Placebo

Sites

38 sites in 5 countries

United States 21, Japan 7, Canada 5, South Korea 3, China 2