PF-06651600 for the Treatment of Alopecia Areata

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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