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CompletedPhase 3

Long-Term PF-06651600 for the Treatment of Alopecia Areata

Key facts

Where
Aurora, Bellaire, Beverly Hills, Birmingham, Boston, Boynton Beach, Chapel Hill, Chevy Chase, Chicago, Cleveland, Indianapolis, Iowa City, Irvine, Meridian, Minneapolis, Murrieta, New Haven, New York, Oakbrook Terrace, Omaha, Orange Park, Portland, San Francisco, Santa Ana, Skokie, Springfield, Tampa, Tulsa, Verona, Vienna, and Washington D.C., United StatesSee the 47 sites
Phase
Phase 3

Where in United States

  • University of Colorado Anschutz Medical CampusAurora, United StatesNo longer taking part
  • University of Colorado Hospital Clinical and Translational Research CenterAurora, United StatesNo longer taking part
  • University of Colorado Hospital Outpatient PavilionAurora, United StatesNo longer taking part
  • The University of Texas Health Science Center at HoustonBellaire, United StatesNo longer taking part
  • Mosaic DermatologyBeverly Hills, United StatesNo longer taking part
  • The University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
  • The University of Alabama at Birmingham Hosptial Outreach LabBirmingham, United StatesNo longer taking part
  • The University of Alabama at Birmingham, Department of DermatologyBirmingham, United StatesNo longer taking part
  • Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)Boston, United StatesNo longer taking part
  • Siperstein Dermatology GroupBoynton Beach, United StatesNo longer taking part
  • UNC CTRCChapel Hill, United StatesNo longer taking part
  • UNC Dermatology and Skin Cancer CenterChapel Hill, United StatesNo longer taking part
  • Medstar Georgetown University Hospital - Department of DermatologyChevy Chase, United StatesNo longer taking part
  • Northwestern Medical GroupChicago, United StatesNo longer taking part
  • Northwestern MedicineChicago, United StatesNo longer taking part
  • Northwestern Medicine Diagnostic Testing CenterChicago, United StatesNo longer taking part
  • Northwestern Memorial Hospital Investigational Drug Service PharmacyChicago, United StatesNo longer taking part
  • Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesNo longer taking part
  • University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
  • Univ of California, Irvine, Dermatology Clinical Research CenterIrvine, United StatesNo longer taking part
  • Velocity Clinical Research, BoiseMeridian, United StatesNo longer taking part
  • University of Minnesota Clinical Research Unit (CRU)Minneapolis, United StatesNo longer taking part
  • University of Minnesota Lillehei Clinical Research Unit (LCRU)Minneapolis, United StatesNo longer taking part
  • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette LukeMinneapolis, United StatesNo longer taking part
  • Dermatology Specialists Inc.Murrieta, United StatesNo longer taking part
  • Yale School of Medicine, Yale Center for Clinical InvestigationsNew Haven, United StatesNo longer taking part
  • Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
  • NYU School of Medicine, The Ronald O. Perelman Department of DermatologyNew York, United StatesNo longer taking part
  • Pura Dermatology (in c/o TrialSpark, Inc)New York, United StatesNo longer taking part
  • Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)Oakbrook Terrace, United StatesNo longer taking part
  • Skin Specialists PC (Schlessinger MD)Omaha, United StatesNo longer taking part
  • Park Avenue DermatologyOrange Park, United StatesNo longer taking part
  • Oregon Medical Research CenterPortland, United StatesNo longer taking part
  • Kaiser Permanente Clinical Trials UnitSan Francisco, United StatesNo longer taking part
  • University of California San FranciscoSan Francisco, United StatesNo longer taking part
  • Southern California Dermatology, Inc.Santa Ana, United StatesNo longer taking part
  • NorthShore University HealthSystem Dermatology Clinical Trials UnitSkokie, United StatesNo longer taking part
  • Southern Illinois University School of MedicineSpringfield, United StatesNo longer taking part
  • ForCare Clinical ResearchTampa, United StatesNo longer taking part
  • Vital Prospects Clinical Research Institute, P.C.Tulsa, United StatesNo longer taking part
  • Schweiger Dermatology, P.C.Verona, United StatesNo longer taking part
  • Tamjidi Skin Institute (in c/o TrialSpark, Inc)Vienna, United StatesNo longer taking part
  • Medstar Georgetown University Hospital - Department of OtolaryngologyWashington D.C., United StatesNo longer taking part
  • Medstar Georgetown University Hospital - Department of PediatricsWashington D.C., United StatesNo longer taking part
  • Medstar Georgetown University Hospital-Dept of OtolaryngologyWashington D.C., United StatesNo longer taking part
  • MedStar Washington Hospital CenterWashington D.C., United StatesNo longer taking part

Trial details

Who runs it
Pfizer
Trial code
NCT04006457EU 2023-509801-59-00
Record updated
9 April 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:; Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed; De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis; De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis; No evidence of terminal scalp hair regrowth within 6 months (de novo only); Current episode of terminal scalp hair loss <=10 years (de novo only).

Exclusion: For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:; Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive; Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1; Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit; History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster.

ClinicalTrials.gov NCT04006457 · EU CTIS 2023-509801-59-00