A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alopecia Areata
In brief
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.
Key facts
- Study ID
- NCT05556265
- Run by
- Bristol-Myers Squibb
- People needed
- 94
- Starts
- 2022-11-08
- Expected to finish
- 2024-05-16
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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.
Where it is running
- Local Institution - 0016 — Santa Monica, California, United States
- Local Institution - 0036 — New Haven, Connecticut, United States
- Local Institution - 0018 — Tampa, Florida, United States
- Local Institution - 0023 — Clinton Township, Michigan, United States
- Local Institution - 0024 — New York, New York, United States
- Local Institution - 0019 — Chapel Hill, North Carolina, United States
- Local Institution - 0011 — Portland, Oregon, United States
- Local Institution - 0032 — Pittsburgh, Pennsylvania, United States
- Local Institution - 0012 — Austin, Texas, United States
- Local Institution - 0013 — Houston, Texas, United States
- Local Institution - 0014 — San Antonio, Texas, United States
- Local Institution - 0017 — South Jordan, Utah, United States
- Local Institution - 0003 — Kogarah, New South Wales, Australia
- Local Institution - 0005 — Carlton, Victoria, Australia
- Local Institution - 0015 — Winnipeg, Manitoba, Canada
- Local Institution - 0021 — Markham, Ontario, Canada
- Local Institution - 0009 — Peterborough, Ontario, Canada
- Local Institution - 0010 — Richmond Hill, Ontario, Canada
- Local Institution - 0034 — Montreal, Quebec, Canada
- Local Institution - 0027 — Québec, Quebec, Canada
- Local Institution - 0033 — Nice, France
- Local Institution - 0020 — Paris, France
- Local Institution - 0031 — Hamamatsu, Japan
- Local Institution - 0028 — Kōtoku, Japan
- Local Institution - 0030 — Mitaka-Shi, Japan
Full record on ClinicalTrials.gov
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