At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
In Brief
A Phase 3 clinical trial evaluating PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, and 1 other intervention for Alopecia Areata. Completed, enrolled 1,057 participants across 144 sites in 17 countries.
Detailed 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.
Study Details
Timeline
Interventions
50 mg oral tablets/capsules
Single intramuscular injection administered to patients participating in the vaccine sub-study
Single intramuscular injection administered to patients participating in the vaccine sub-study