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NCT07029828Phase 3
Key facts
Phase 3, randomised, double-blind trial of ritlecitinib tosilate in alopecia areata (2 arms), sponsored by Pfizer. Primary endpoints: Incidence of treatment-emergent adverse events up to 3 years and Incidence of Serious Adverse Events and AEs leading to permanent discontinuation up to 3 years. Started Sep 2025; status: recruiting.
Ritlecitinib higher dose
Participants receive 1 ritlecitinib higher dose capsule QD and 1 placebo lower dose capsule QD orally for up to 3 years.
Ritlecitinib lower dose
Participants receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for up to 3 years.
Participants with severe alopecia areata who completed previous ritlecitinib studies B7981027 or B7981031.
Incidence of treatment-emergent adverse events
Incidence of Serious Adverse Events and AEs leading to permanent discontinuation
Proportion of participants achieving absolute Severity of Alopecia Tool score ≤10
Proportion of participants achieving absolute Severity of Alopecia Tool score ≤20
Change from baseline in Severity of Alopecia Tool score
Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment
Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment
Proportion of participants achieving Patient Global Impression of Change response
Change from baseline in PROMIS Parent Proxy Anxiety Symptoms T-score
Change from baseline in Behavior Rating Inventory of Executive Function T-scores
Beyond the preview
Full results, competitive context and analysis are in the Gosset platform.
Available in the Gosset platform where reported.
Available in the Gosset platform where reported.
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