A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Deucravacitinib
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deucravacitinib Dose 1<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Deucravacitinib Dose 2<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Other: Placebo<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 |  | Baseline, Week 24 | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Baseline up to Week 56 | 
| Number of Participants with Adverse Events (AEs) |  | Baseline up to Week 56 | 
| Number of Participants with AEs Leading to Study Discontinuation |  | Baseline up to Week 56 | 
| Number of Participants with AEs of Interest (AEIs) |  | Baseline up to Week 56 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Baseline up to Week 56 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Baseline up to Week 56 | 
| Number of Participants with Physical Examination Abnormalities |  | Baseline up to Week 56 | 
| Number of Participants with Vital Sign Abnormalities |  | Baseline up to Week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a ≥ 50% reduction in SALT Score (SALT50 Response) from Baseline at Week 24 |  | Week 24 | 
| Proportion of Participants with a SALT Score ≤ 20 at Week 24 |  | Week 24 | 
| Proportion of Participants with an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 with at least a 2-Point Change from Baseline |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deucravacitinib, IM011134, BMS-986165