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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05556265
• Other study ID #: IM011-134
• Secondary ID: U1111-1246-17672
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 8, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: January 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0005	Carlton	Victoria
Australia	Local Institution - 0003	Kogarah	New South Wales
Canada	Local Institution - 0021	Markham	Ontario
Canada	Local Institution - 0034	Montreal	Quebec
Canada	Local Institution - 0009	Peterborough	Ontario
Canada	Local Institution - 0027	Québec	Quebec
Canada	Local Institution - 0010	Richmond Hill	Ontario
Canada	Local Institution - 0015	Winnipeg	Manitoba
France	Local Institution - 0033	Nice
France	Local Institution - 0020	Paris
Japan	Local Institution - 0031	Hamamatsu-Shi
Japan	Local Institution - 0028	Koto-Ku
Japan	Local Institution - 0030	Mitaka-Shi
Japan	Local Institution - 0029	Shinjuku-Ku
Poland	Local Institution - 0025	Warsaw
Poland	Local Institution - 0026	Wroclaw	DS
United States	Local Institution - 0012	Austin	Texas
United States	Local Institution - 0019	Chapel Hill	North Carolina
United States	Local Institution - 0023	Clinton Township	Michigan
United States	Local Institution - 0013	Houston	Texas
United States	Local Institution - 0036	New Haven	Connecticut
United States	Mount Sinai Medical Center - Faculty Practice Associates (FPA) - Dermatology Associates	New York	New York
United States	University of Pittsburgh Medical Center (UPMC) - Arthritis and Autoimmunity Center - Falk Clinic	Pittsburgh	Pennsylvania
United States	Local Institution - 0011	Portland	Oregon
United States	Local Institution - 0014	San Antonio	Texas
United States	Local Institution - 0016	Santa Monica	California
United States	Local Institution - 0017	South Jordan	Utah
United States	Local Institution - 0018	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Severity of Alopecia Tool (SALT) Score at Week 24		Baseline, Week 24
Primary	Number of Participants with Serious Adverse Events (SAEs)		Baseline up to Week 56
Primary	Number of Participants with Adverse Events (AEs)		Baseline up to Week 56
Primary	Number of Participants with AEs Leading to Study Discontinuation		Baseline up to Week 56
Primary	Number of Participants with AEs of Interest (AEIs)		Baseline up to Week 56
Primary	Number of Participants with Clinical Laboratory Abnormalities		Baseline up to Week 56
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Baseline up to Week 56
Primary	Number of Participants with Physical Examination Abnormalities		Baseline up to Week 56
Primary	Number of Participants with Vital Sign Abnormalities		Baseline up to Week 56
Secondary	Proportion of participants with a = 50% reduction in SALT Score (SALT50 Response) from Baseline at Week 24		Week 24
Secondary	Proportion of Participants with a SALT Score = 20 at Week 24		Week 24
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting