Summary

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

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 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, San Francisco accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente Clinical Trials Unit accepting new patients
    San Francisco California 94118 United States

Lead Scientist

  • Sarah Arron
    My research focuses on the pathogenesis of cutaneous squamous cell carcinoma. As a Mohs Micrographic surgeon in the department of Dermatology, I lead the High Risk Skin Cancer Program, a practice devoted to the care of patients at risk for skin cancer due to solid organ transplant and other iatrogenic immunosuppression, HIV infection, and genetic conditions predisposing to cutaneous malignancy.

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
NCT03732807
Phase
Phase 2/3
Study Type
Interventional
Last Updated