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

Last updated: March 6, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

4

Condition

Skin Wounds

Warts

Rash

Treatment

Deucravacitinib

Placebo

Clinical Study ID

NCT05478499
IM011-220
U1111-1274-7417
2022-000797-26
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6months or more. Stable psoriasis is defined as no morphology changes or significantflares 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 GlobalAssessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp SeverityIndex (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

Exclusion Criteria:

  • Target Disease Exceptions:
  1. Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic ordrug-induced psoriasis) at Screening or Day 1 Other protocol-definedinclusion/exclusion criteria apply

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Deucravacitinib
Phase: 4
Study Start date:
October 06, 2022
Estimated Completion Date:
October 17, 2024

Connect with a study center

  • Local Institution - 0019

    Paris, 75010
    France

    Site Not Available

  • Local Institution - 0040

    Romans sur Isere Cedex, 26102
    France

    Site Not Available

  • Local Institution - 0044

    Rouen, 76031
    France

    Site Not Available

  • Local Institution - 0044

    Rouen Cedex, 76031
    France

    Site Not Available

  • Local Institution - 0035

    Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Local Institution - 0038

    Witten, Deutschland 58454
    Germany

    Site Not Available

  • Local Institution - 0013

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Local Institution - 0050

    Luebeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Local Institution - 0048

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution - 0012

    Kiel, 24105
    Germany

    Site Not Available

  • Local Institution - 0012

    Luebeck, 23538
    Germany

    Site Not Available

  • Local Institution - 0011

    Mahlow, 15831
    Germany

    Site Not Available

  • Local Institution - 0037

    Lodz, Woj.Lodzkie 90-436
    Poland

    Site Not Available

  • Local Institution - 0046

    Lodz, Woj.Lodzkie 90-436
    Poland

    Site Not Available

  • Local Institution - 0026

    Krakow, 30438
    Poland

    Site Not Available

  • Local Institution - 0017

    Lodz, 90-436
    Poland

    Site Not Available

  • Local Institution - 0014

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Local Institution - 0027

    Rzeszow, 35-001
    Poland

    Site Not Available

  • Local Institution - 0015

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Local Institution - 0036

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Local Institution - 0031

    London, Greater London SE1 9RT
    United Kingdom

    Site Not Available

  • Local Institution - 0045

    Salford, Greater Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Local Institution - 0039

    Southampton, Hampshire SO16 6DU
    United Kingdom

    Site Not Available

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

  • Local Institution - 0001

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Keck School of Medicine of University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Local Institution - 0007

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Local Institution - 0041

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Lawrence J. Green, MD. LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Local Institution - 0022

    Rockville, Maryland 20850
    United States

    Site Not Available

  • ALLCUTIS Research, LLC

    Beverly, Massachusetts 01915
    United States

    Active - Recruiting

  • Local Institution - 0008

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Henry Ford Medical Center -

    Bloomfield Hills, Michigan 48302
    United States

    Active - Recruiting

  • Local Institution - 0047

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Local Institution - 0002

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Active - Recruiting

  • Local Institution - 0002

    New Brighton, Minnesota 55432
    United States

    Site Not Available

  • Local Institution - 0049

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central NJ

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

  • Forest Hill Dermatology Group

    Kew Gardens, New York 11415
    United States

    Active - Recruiting

  • Local Institution - 0051

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Local Institution - 0003

    Portland, Oregon 97201
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223-6683
    United States

    Active - Recruiting

  • Local Institution - 0005

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Local Institution - 0033

    Houston, Texas 77004
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Local Institution - 0004

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Utah MidValley Dermatology

    Murray, Utah 84107
    United States

    Site Not Available

  • Local Institution - 0006

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Clinical Research , Inc

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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