Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
NCT ID: NCT05478499
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
154 participants
INTERVENTIONAL
2022-10-06
2024-10-17
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
Deucravacitinib
Specified dose on specified days
Placebo then Deucravacitinib
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
3. Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
4. ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
5. Evidence of plaque psoriasis in a non-scalp area
6. Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion Criteria
18 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_CHAIR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Hot Springs, Arkansas, United States
Local Institution - 0007
Indianapolis, Indiana, United States
Local Institution - 0041
Louisville, Kentucky, United States
Local Institution - 0022
Rockville, Maryland, United States
Local Institution - 0008
Beverly, Massachusetts, United States
Local Institution - 0047
Bloomfield Hills, Michigan, United States
Local Institution - 0002
New Brighton, Minnesota, United States
Local Institution - 0049
East Windsor, New Jersey, United States
Local Institution - 0051
Kew Gardens, New York, United States
Local Institution - 0003
Portland, Oregon, United States
Local Institution - 0005
Pittsburgh, Pennsylvania, United States
Local Institution - 0033
Houston, Texas, United States
Local Institution - 0004
San Antonio, Texas, United States
Local Institution - 0006
Norfolk, Virginia, United States
Local Institution - 0019
Paris, , France
Local Institution - 0040
Romans-sur-Isère, , France
Local Institution - 0044
Rouen, , France
Local Institution - 0038
Witten, Deutschland, Germany
Local Institution - 0013
Frankfurt am Main, Hesse, Germany
Local Institution - 0048
Hamburg, , Germany
Local Institution - 0012
Lübeck, , Germany
Local Institution - 0011
Mahlow, , Germany
Local Institution - 0026
Krakow, , Poland
Local Institution - 0017
Lodz, , Poland
Local Institution - 0014
Rzeszów, , Poland
Local Institution - 0015
Wroclaw, , Poland
Local Institution - 0031
London, Greater London, United Kingdom
Local Institution - 0045
Salford, Greater Manchester, United Kingdom
Local Institution - 0039
Southampton, HAMPSHIRE, United Kingdom
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
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-000797-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1274-7417
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-220
Identifier Type: -
Identifier Source: org_study_id
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