Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

NCT05478499 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: IM011-2202022-000797-26U1111-1274-7417
• Study Type: interventional
• Target: 154
• Locations: 5 countries
• Sites: 29

Brief Summary

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

Conditions

Psoriasis

Keywords

Scalp Psoriasis; BMS-986165; Deucravacitinib; Psoriasis; Psoriasis Special Sites

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16

  ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.

  Baseline and Week 16

Secondary Outcomes (8)

• Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16

  Baseline and Week 16

• Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16

  Baseline and Week 16

• Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16

  Baseline and Week 16

• Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

  From week 0 through week 16

• Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)

  From week 0 through week 16

Study Arms (2)

Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Placebo then Deucravacitinib

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Deucravacitinib; Placebo then Deucravacitinib

Placebo OTHER

Specified dose on specified days

Placebo then Deucravacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
• 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
• ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
• Evidence of plaque psoriasis in a non-scalp area
• Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis

You may not qualify if:

• Target Disease Exceptions:

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (29)

Local Institution - 0001

Hot Springs, Arkansas, 71913, United States

Location

Local Institution - 0007

Indianapolis, Indiana, 46256, United States

Location

Local Institution - 0041

Louisville, Kentucky, 40217, United States

Location

Local Institution - 0022

Rockville, Maryland, 20850, United States

Location

Local Institution - 0008

Beverly, Massachusetts, 01915, United States

Location

Local Institution - 0047

Bloomfield Hills, Michigan, 48302, United States

Location

Local Institution - 0002

New Brighton, Minnesota, 55432, United States

Location

Local Institution - 0049

East Windsor, New Jersey, 08520, United States

Location

Local Institution - 0051

Kew Gardens, New York, 11415, United States

Location

Local Institution - 0003

Portland, Oregon, 97201, United States

Location

Local Institution - 0005

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0033

Houston, Texas, 77004, United States

Location

Local Institution - 0004

San Antonio, Texas, 78229, United States

Location

Local Institution - 0006

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0019

Paris, 75010, France

Location

Local Institution - 0040

Romans-sur-Isère, 26102, France

Location

Local Institution - 0044

Rouen, 76031, France

Location

Local Institution - 0038

Witten, Deutschland, 58454, Germany

Location

Local Institution - 0013

Frankfurt am Main, Hesse, 60590, Germany

Location

Local Institution - 0048

Hamburg, 20246, Germany

Location

Local Institution - 0012

Lübeck, 23538, Germany

Location

Local Institution - 0011

Mahlow, 15831, Germany

Location

Local Institution - 0026

Krakow, 30438, Poland

Location

Local Institution - 0017

Lodz, 90-436, Poland

Location

Local Institution - 0014

Rzeszów, 35-055, Poland

Location

Local Institution - 0015

Wroclaw, 51-685, Poland

Location

Local Institution - 0031

London, Greater London, SE1 9RT, United Kingdom

Location

Local Institution - 0045

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Local Institution - 0039

Southampton, HAMPSHIRE, SO16 6DU, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 28, 2022
• Study Start: October 6, 2022
• Primary Completion: January 11, 2024
• Study Completion: October 17, 2024
• Last Updated: October 28, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-09

Locations

GB (3); US (14); DE (5); PL (4); FR (3)