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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2024-10-17

Brief Summary

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The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deucravacitinib

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo then Deucravacitinib

Group Type PLACEBO_COMPARATOR

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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Deucravacitinib

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-986165

Eligibility Criteria

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Inclusion Criteria

1. Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
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

* Target Disease Exceptions:
Minimum Eligible Age

18 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_CHAIR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Hot Springs, Arkansas, United States

Site Status

Local Institution - 0007

Indianapolis, Indiana, United States

Site Status

Local Institution - 0041

Louisville, Kentucky, United States

Site Status

Local Institution - 0022

Rockville, Maryland, United States

Site Status

Local Institution - 0008

Beverly, Massachusetts, United States

Site Status

Local Institution - 0047

Bloomfield Hills, Michigan, United States

Site Status

Local Institution - 0002

New Brighton, Minnesota, United States

Site Status

Local Institution - 0049

East Windsor, New Jersey, United States

Site Status

Local Institution - 0051

Kew Gardens, New York, United States

Site Status

Local Institution - 0003

Portland, Oregon, United States

Site Status

Local Institution - 0005

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0033

Houston, Texas, United States

Site Status

Local Institution - 0004

San Antonio, Texas, United States

Site Status

Local Institution - 0006

Norfolk, Virginia, United States

Site Status

Local Institution - 0019

Paris, , France

Site Status

Local Institution - 0040

Romans-sur-Isère, , France

Site Status

Local Institution - 0044

Rouen, , France

Site Status

Local Institution - 0038

Witten, Deutschland, Germany

Site Status

Local Institution - 0013

Frankfurt am Main, Hesse, Germany

Site Status

Local Institution - 0048

Hamburg, , Germany

Site Status

Local Institution - 0012

Lübeck, , Germany

Site Status

Local Institution - 0011

Mahlow, , Germany

Site Status

Local Institution - 0026

Krakow, , Poland

Site Status

Local Institution - 0017

Lodz, , Poland

Site Status

Local Institution - 0014

Rzeszów, , Poland

Site Status

Local Institution - 0015

Wroclaw, , Poland

Site Status

Local Institution - 0031

London, Greater London, United Kingdom

Site Status

Local Institution - 0045

Salford, Greater Manchester, United Kingdom

Site Status

Local Institution - 0039

Southampton, HAMPSHIRE, United Kingdom

Site Status

Countries

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United States France Germany Poland United Kingdom

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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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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