PF-06651600 for the Treatment of Alopecia Areata

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

This is a global Phase 2b/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 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Key facts

Study ID

NCT03732807

Run by

Pfizer

People needed

718

Starts

2018-12-03

Expected to finish

2021-06-24

Last updated by the study team

2022-02-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of alopecia areata with no other cause of hair loss
• ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
• Current episode of hair loss ≤10 years

You may not qualify if…

• Other types of alopecia or other diseases that can cause hair loss
• Other scalp diseases that could interfere with assessment of hair loss/regrowth
• Subjects with shaved heads must not enter the study until hair has grown back \& is considered stable by the investigator
• Any previous use of any Janus kinase (JAK) inhibitor

Where it is running

• The University of Alabama at Birmingham, Department of Dermatology — Birmingham, Alabama, United States
• The University of Alabama at Birmingham, Department of Dermatology — Birmingham, Alabama, United States
• Mosaic Dermatology — Beverly Hills, California, United States
• University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center — Irvine, California, United States
• Dermatology Specialists, Inc. — Murrieta, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Kaiser Permanente Clinical Trials Unit — San Francisco, California, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• University of Colorado Hospital Clinical and Translational Research Center — Aurora, Colorado, United States
• University of Colorado Hospital Outpatient Pavillion — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Church Street Research Unit — New Haven, Connecticut, United States
• Medstar Georgetown University Hospital Center-Department of Otolaryngology — Washington D.C., District of Columbia, United States
• Medstar Washington Hospital Center-Claude Nogay Research Pharmacy — Washington D.C., District of Columbia, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Medstar Georgetown University Hospital Center-Department of Pediatrics — Washington D.C., District of Columbia, United States
• Siperstein Dermatology Group — Boynton Beach, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Medicine Diagnostic Testing Center — Chicago, Illinois, United States
• Northwestern Medicine — Chicago, Illinois, United States
• The University of Alabama at Birmingham Hospital Outreach Lab — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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