Summary

Eligibility
for people ages 18-65 (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 efficacy of Deucravacitinib versus placebo at Week 24 and safety and tolerability of Deucravacitinib versus placebo in adults with Alopecia Areata.

Official Title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata

Keywords

Alopecia Areata, Deucravacitinib, IM011134, BMS-986165, Alopecia

Eligibility

You can join if…

Open to people ages 18-65

  • Documented clinical diagnosis of Alopecia Areata (AA) for at least 6 months.
  • Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth [> 10%] over the last 6 months)
  • SALT score ≥ 50 at Screening and Day 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included.

You CAN'T join if...

  • Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc.
  • Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score.
  • Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score.

Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center
    Irvine California 92697 United States
  • Dermatology Institute & Skin Care Center (DISCC)
    Santa Monica California 90404-2120 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT05556265
Phase
Phase 2 Alopecia Areata Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated