Adults from 18 to 65 years of age with a documented clinical diagnosis of alopecia areata (AA) for at least 6 months are needed for this study. Eligible individuals must have a current episode of scalp hair loss lasting at least 6 months, that affects 50% or more of the scalp (duration not exceeding 8 years), with scalp hair loss that has been stable (no significant spontaneous regrowth) over the last 6 months. People with complete scalp hair loss with or without body hair involvement can also be included.
Participants will receive investigational oral medication (active study drug) or placebo via tablets. During the active treatment period, all participants will receive active study drug. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 60 weeks and involve about 14 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: March 19, 2023
NCT05556265
Bristol-Myers Squibb
Brief 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.
Condition or Disease:
Alopecia Areata
Intervention/Treatment:
Drug: DeucravacitinibPhase:
Phase 2
Ages Eligible for Study:
18 Years and 65 Years (Adult)
Sexes Eligible for Study:
All
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:
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.
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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