Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Alopecia Areata Alopecia Alopecia totalis Alopecia universalis Patchy hair loss Diffuse hair loss Hair loss Hair disease PF-06651600 Ritlecitinib PF-06651600 Induction Dose PF-06651600 Maintenance Dose #1 PF-06651600 Maintenance Dose #2 PF-06651600 Maintenance Dose #3 Sequence A Sequence B Sequence C Sequence D Sequence E Sequence F Sequence G

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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

Locations

  • University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center
    Irvine California 92697 United States
  • Southern California Dermatology, Inc.
    Santa Ana California 92701 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT03732807
Phase
Phase 2/3
Study Type
Interventional
Last Updated