A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
NCT ID: NCT05556265
Last Updated: 2025-05-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
94 participants
INTERVENTIONAL
2022-11-08
2024-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Deucravacitinib Dose 1
Deucravacitinib
Specified dose on specified days
Placebo
Placebo was administered.
Deucravacitinib Dose 2
Deucravacitinib
Specified dose on specified days
Placebo
Placebo was administered.
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Deucravacitinib
Specified dose on specified days
Placebo
Placebo was administered.
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Placebo was administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
Local Institution - 0036
New Haven, Connecticut, United States
Local Institution - 0018
Tampa, Florida, United States
Local Institution - 0023
Clinton Township, Michigan, United States
Local Institution - 0024
New York, New York, United States
Local Institution - 0019
Chapel Hill, North Carolina, United States
Local Institution - 0011
Portland, Oregon, United States
Local Institution - 0032
Pittsburgh, Pennsylvania, United States
Local Institution - 0012
Austin, Texas, United States
Local Institution - 0013
Houston, Texas, 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 - 0005
Carlton, Victoria, Australia
Local Institution - 0015
Winnipeg, Manitoba, Canada
Local Institution - 0021
Markham, Ontario, Canada
Local Institution - 0009
Peterborough, Ontario, Canada
Local Institution - 0010
Richmond Hill, Ontario, Canada
Local Institution - 0034
Montreal, Quebec, Canada
Local Institution - 0027
Québec, Quebec, Canada
Local Institution - 0033
Nice, , France
Local Institution - 0020
Paris, , France
Local Institution - 0031
Hamamatsu, , Japan
Local Institution - 0028
Kōtoku, , Japan
Local Institution - 0030
Mitaka-Shi, , Japan
Local Institution - 0029
Shinjuku-Ku, , Japan
Local Institution - 0026
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0025
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
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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