Trials / Completed
CompletedNCT04006457
Long-Term PF-06651600 for the Treatment of Alopecia Areata
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,057 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06651600 | 50 mg oral tablets/capsules |
| BIOLOGICAL | Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine | Single intramuscular injection administered to patients participating in the vaccine sub-study |
| BIOLOGICAL | Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine | Single intramuscular injection administered to patients participating in the vaccine sub-study |
Timeline
- Start date
- 2019-07-18
- Primary completion
- 2024-06-25
- Completion
- 2026-02-26
- First posted
- 2019-07-05
- Last updated
- 2026-04-09
- Results posted
- 2025-08-14
Locations
144 sites across 17 countries: United States, Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Germany, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04006457. Inclusion in this directory is not an endorsement.