Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata

Keywords

Alopecia Areata, T-cell-mediated autoimmune skin disorder, Alopecia, APD334, Etrasimod, Hair loss, Etrasimod 2 mg, Etrasimod 3 mg

Eligibility

You can join if…

Open to people ages 18-70

  • Men or women between ≥18 and ≤70 years of age at the time of informed consent
  • Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
  • Current episode of hair loss for ≥6 months but <5 years
  • Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
  • Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study

You CAN'T join if...

  • History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
  • Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
  • Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
  • Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

Locations

  • University of California,Irvine
    Irvine California 92697 United States
  • First OC Dermatology
    Fountain Valley California 92708 United States
  • Prospect Optometry
    Lomita California 90717 United States
  • Torrance Clinical Research Institute,Inc.
    Lomita California 90717 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04556734
Phase
Phase 2 Alopecia Research Study
Study Type
Interventional
Participants
About 80 people participating
Last Updated