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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 90 人开始时间: 2022年10月27日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•Men and non-pregnant non-breastfeeding women aged = 18 years to = 65 years at the time of the Screening visit.
•SALT score = 50 at Screening and Day 1
•Alopecia Areata Investigator Global Assessment ( AA-IGA) grade = 3 at Screening and Day 1
•Duration of current episode of scalp hair loss (at Screening) must be at least 6 months, and not > 8 years, must affect = 50% of the scalp, and scalp hair loss should be stable (ie, no significant spontaneous regrowth [> 10%] over the last 6 months).
•Other protocol defined inclusion criteria apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•History of lack of response to ustekinumab, in the opinion of the investigator, (or any other therapeutic agent targeted to IL-12, IL-17, or IL-23) after at least 3 months of therapy
•History of lack of response to a JAK inhibitor (eg, tofacitinib, ruxolitinib), in the opinion of the investigator
•Thyroid medication or thyroid replacement therapies, if used, must be stable for 2 months and be maintained as such throughout the study
•Any ongoing treatment known to affect hair growth including, but not limited to, topical steroids (applied to the scalp), intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone, tacrolimus, cyclosporine, finasteride/minoxidil (oral or topical) or other medication that cannot be discontinued at least 4 weeks prior to study intervention initiation (Day 1) and throughout the study.
•Other protocol defined exclusion criteria apply

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