A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Alopecia Areata
Age (in years)
18 - 65
Phase
Phase 2
Participants needed
90
Est. Completion Date
Dec 30, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05556265
Study number
IM011134
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?