NCT02974868

Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	PF-06651600	200 mg QD during induction and 50 mg QD during Maintenance
DRUG	PF-06700841	60 mg QD during induction and 30 mg QD during maintenance
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-12-15
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2016-11-29
• Last updated: 2020-05-26
• Results posted: 2020-05-26

Locations

55 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study