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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 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.

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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.

Conditions Studied

Alopecia Areata

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

FieldValue
Enrollment Target 1,052 participants
Start Date 2019-07-18
Est. Completion 2026-03-01
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT04006457

The ClinicalTrials.gov registry entry for NCT04006457 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,052 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,915-participant average among 26 other Alopecia Areata trials with a reported enrollment target (45% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.