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NCT04006457 · ClinicalTrials.gov registry record · Phase 3
Long-Term PF-06651600 for the Treatment of Alopecia Areata
A Phase 3 study of Alopecia Areata, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 1,052
- Enrollment target
- 20
- Study locations
NCT04006457: Active Phase 3 study of Alopecia Areata, sponsored by Pfizer.
NCT04006457 is a Phase 3 study of Alopecia Areata that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1,052 participants, below the 1,915-participant average among 26 other Alopecia Areata trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04006457, a Phase 3 study of Alopecia Areata, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,052 participants
- Enrollment target
- 20
- Study locations
Study 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
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.
Conditions Studied
Interventions
- DRUG PF-06651600
- BIOLOGICAL Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
- BIOLOGICAL Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Study Locations (20)
California
- Mosaic Dermatology - Beverly Hills
- Univ of California, Irvine, Dermatology Clinical Research Center - Irvine
- Dermatology Specialists Inc. - Murrieta
- University of California, San Francisco - San Francisco
- Kaiser Permanente Clinical Trials Unit - San Francisco
- Southern California Dermatology, Inc. - Santa Ana
District of Columbia
- Medstar Georgetown University Hospital - Department of Otolaryngology - Washington D.C.
- Medstar Georgetown University Hospital-Dept of Otolaryngology - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
- Medstar Georgetown University Hospital - Department of Pediatrics - Washington D.C.
Alabama
- The University of Alabama at Birmingham Hosptial Outreach Lab - Birmingham
- The University of Alabama at Birmingham - Birmingham
- The University of Alabama at Birmingham, Department of Dermatology - Birmingham
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- University of Colorado Hospital Clinical and Translational Research Center - Aurora
- University of Colorado Hospital Outpatient Pavilion - Aurora
Florida
- Siperstein Dermatology Group - Boynton Beach
- Park Avenue Dermatology - Orange Park
- ForCare Clinical Research - Tampa
Connecticut
- Yale School of Medicine, Yale Center for Clinical Investigations - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,052 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 3 |
What the registry record for NCT04006457 still lists
NCT04006457 is an interventional study that assigns participants to a tested intervention. Its 1,052 participants enrollment target places it among the larger protocols in the corpus, below the 1,915-participant average among 26 other Alopecia Areata trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 3 interventions - of which PF-06651600 is the first listed.
NCT04006457 names 20 study sites across 6 states, led by California, District of Columbia, Alabama.
Frequently Asked Questions
What is clinical trial NCT04006457 about?
NCT04006457 is a clinical study titled "Long-Term PF-06651600 for the Treatment of Alopecia Areata". 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 ...
What is the current status of trial NCT04006457?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,052 participants. The study started on 2019-07-18. Estimated completion is 2026-03-01.
What conditions does trial NCT04006457 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT04006457?
The interventions under investigation include: PF-06651600 (DRUG), Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine (BIOLOGICAL), Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04006457?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04006457 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04006457's enrollment target sits among peer trials
1,052 7th of 26 higher than 20 of 26 other Alopecia Areata trials
participants (enrollment target), bucketed by value
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