Summary

for people ages 12 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This is a global Phase 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 alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

Official Title

A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Keywords

Alopecia Areata Alopecia Alopecia totalis Alopecia universalis Patchy hair loss Diffuse hair loss Hair loss Hair disease PF-06651600

Eligibility

You can join if…

Open to people ages 12 years and up

for de novo participants and participants from Study B7931005 and

B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
  • >=25% hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
  • No evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss <=10 years

You CAN'T join if...

for de novo participants and participants from Study B7931005 and

B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • Other types of diseases that can cause hair loss or that could interfere with assessment of hair loss/regrowth
  • Participants with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator

All participants:

  • Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94115 United States
  • Kaiser Permanente Clinical Trials Unit not yet accepting patients
    San Francisco California 94118 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04006457
Phase
Phase 3
Study Type
Interventional
Last Updated