NCT03732807

PF-06651600 for the Treatment of Alopecia Areata

A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 718 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	PF-06651600 Induction Dose	Oral tablets taken once daily (QD)
DRUG	PF-06651600 Maintenance Dose #1	Oral tablets taken QD
DRUG	PF-06651600 Maintenance Dose #2	Oral tablets taken QD
DRUG	PF-06651600 Maintenance Dose #3	Oral tablets taken QD
DRUG	Placebo	Oral tablets taken QD

Timeline

• Start date: 2018-12-03
• Primary completion: 2020-12-31
• Completion: 2021-06-24
• First posted: 2018-11-07
• Last updated: 2022-02-24
• Results posted: 2022-02-24

Locations

155 sites across 18 countries: United States, Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study