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

NCT ID: NCT05556265

Last Updated: 2025-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2024-05-16

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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Deucravacitinib Dose 1

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Placebo was administered.

Deucravacitinib Dose 2

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Placebo was administered.

Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

Group Type PLACEBO_COMPARATOR

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Placebo was administered.

Interventions

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Deucravacitinib

Specified dose on specified days

Intervention Type DRUG

Placebo

Placebo was administered.

Intervention Type OTHER

Other Intervention Names

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BMS-986165

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0016

Santa Monica, California, United States

Site Status

Local Institution - 0036

New Haven, Connecticut, United States

Site Status

Local Institution - 0018

Tampa, Florida, United States

Site Status

Local Institution - 0023

Clinton Township, Michigan, United States

Site Status

Local Institution - 0024

New York, New York, United States

Site Status

Local Institution - 0019

Chapel Hill, North Carolina, United States

Site Status

Local Institution - 0011

Portland, Oregon, United States

Site Status

Local Institution - 0032

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0012

Austin, Texas, United States

Site Status

Local Institution - 0013

Houston, Texas, United States

Site Status

Local Institution - 0014

San Antonio, Texas, United States

Site Status

Local Institution - 0017

South Jordan, Utah, United States

Site Status

Local Institution - 0003

Kogarah, New South Wales, Australia

Site Status

Local Institution - 0005

Carlton, Victoria, Australia

Site Status

Local Institution - 0015

Winnipeg, Manitoba, Canada

Site Status

Local Institution - 0021

Markham, Ontario, Canada

Site Status

Local Institution - 0009

Peterborough, Ontario, Canada

Site Status

Local Institution - 0010

Richmond Hill, Ontario, Canada

Site Status

Local Institution - 0034

Montreal, Quebec, Canada

Site Status

Local Institution - 0027

Québec, Quebec, Canada

Site Status

Local Institution - 0033

Nice, , France

Site Status

Local Institution - 0020

Paris, , France

Site Status

Local Institution - 0031

Hamamatsu, , Japan

Site Status

Local Institution - 0028

Kōtoku, , Japan

Site Status

Local Institution - 0030

Mitaka-Shi, , Japan

Site Status

Local Institution - 0029

Shinjuku-Ku, , Japan

Site Status

Local Institution - 0026

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Local Institution - 0025

Warsaw, , Poland

Site Status

Countries

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United States Australia Canada France Japan Poland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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U1111-1246-1767

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-000113-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM011-134

Identifier Type: -

Identifier Source: org_study_id

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