A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Reason given: Business objectives have changed
Key facts
- Where
- Austin, Chapel Hill, Clinton Township, Houston, New Haven, New York, Pittsburgh, Portland, San Antonio, Santa Monica, South Jordan, and Tampa, United StatesSee the 12 sites
- Phase
- Phase 2
Where in United States
- Austin, TexasHospital not named in the registryNo longer taking part
- Chapel Hill, North CarolinaHospital not named in the registryNo longer taking part
- Clinton Township, MichiganHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- New Haven, ConnecticutHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
- Portland, OregonHospital not named in the registryNo longer taking part
- San Antonio, TexasHospital not named in the registryNo longer taking part
- Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
- South Jordan, UtahHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05556265
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score; Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc; 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.