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

Phase 2

Terminated

• Conditions: Alopecia Areata
• Interventions: Drug: Deucravacitinib; Other: Placebo

• Registration Number: NCT05556265
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2022-11-08
• Primary Completion: 2024-01-06
• Status Verified: 2024-05
• Study Completion: 2024-05-16
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deucravacitinib Dose 1	Deucravacitinib	-
Deucravacitinib Dose 1	Placebo	-
Deucravacitinib Dose 2	Deucravacitinib	-
Deucravacitinib Dose 2	Placebo	-
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.	Placebo	-
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.	Deucravacitinib	-

Primary Outcome Measures

Name	Time	Method
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
Change from Baseline in Severity of Alopecia Tool (SALT) Score at Week 24	Baseline, Week 24
Number of Participants with Physical Examination Abnormalities	Baseline up to Week 56
Number of Participants with Vital Sign Abnormalities	Baseline up to Week 56
Number of participants with electrocardiogram (ECG) abnormalities	Baseline up to Week 56
Number of Participants with Serious Adverse Events (SAEs)	Baseline up to Week 56
Number of Participants with Clinical Laboratory Abnormalities	Baseline up to Week 56

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a ≥ 50% reduction in SALT Score (SALT50 Response) from Baseline 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
Proportion of Participants with a SALT Score ≤ 20 at Week 24	Week 24

Trial Locations

Locations (28)

Local Institution - 0013; 🇺🇸 Houston, Texas, United States

Local Institution - 0025; 🇵🇱 Warsaw, Poland

Local Institution - 0012; 🇺🇸 Austin, Texas, United States

Local Institution - 0019; 🇺🇸 Chapel Hill, North Carolina, United States

Local Institution - 0032; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0016; 🇺🇸 Santa Monica, California, United States

Local Institution - 0026; 🇵🇱 Wroclaw, DS, Poland

Local Institution - 0018; 🇺🇸 Tampa, Florida, United States

Local Institution - 0011; 🇺🇸 Portland, Oregon, United States

Local Institution - 0036; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0023; 🇺🇸 Clinton Township, Michigan, United States

Local Institution - 0024; 🇺🇸 New York, New York, United States

Local Institution - 0014; 🇺🇸 San Antonio, Texas, United States

Local Institution - 0017; 🇺🇸 South Jordan, Utah, United States

Local Institution - 0003; 🇦🇺 Kogarah, New South Wales, Australia

Local Institution - 0009; 🇨🇦 Peterborough, Ontario, Canada

Local Institution - 0015; 🇨🇦 Winnipeg, Manitoba, Canada

Local Institution - 0010; 🇨🇦 Richmond Hill, Ontario, Canada

Local Institution - 0033; 🇫🇷 Nice, France

Local Institution - 0034; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0027; 🇨🇦 Québec, Quebec, Canada

Local Institution - 0028; 🇯🇵 Koto-Ku, Japan

Local Institution - 0031; 🇯🇵 Hamamatsu-Shi, Japan

Local Institution - 0020; 🇫🇷 Paris, France

Local Institution - 0030; 🇯🇵 Mitaka-Shi, Japan

Local Institution - 0029; 🇯🇵 Shinjuku-Ku, Japan

Local Institution - 0021; 🇨🇦 Markham, Ontario, Canada

Local Institution - 0005; 🇦🇺 Carlton, Victoria, Australia