Long-Term PF-06651600 for the Treatment of Alopecia Areata
Long-Term PF-06651600 for the Treatment of Alopecia Areata
NCT ID: NCT04006457 Phase: PHASE3 Status: COMPLETED Enrollment: 1057 Completion: 2026-02-26
Conditions
Alopecia Areata
Interventions
PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Summary
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.
A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.
Primary Outcome
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit