A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Last updated: July 14, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Terminated

Phase

4

Condition

Rash

Warts

Rosacea

Treatment

Placebo

Deucravacitinib

Clinical Study ID

NCT06042920
IM011-1112
2023-504663-16
U1111-1289-6934
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

  • Men and women diagnosed with stable plaque psoriasis with involvement of thepalm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined asno morphology changes or significant flares of disease activity in the opinion ofthe investigator.

  • Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scaleat both screening visit and Day 1.

  • Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.

  • A total maximum of 5 sterile pustules across both palms and soles limited onlyto psoriatic plaques will be allowed.

  • Evidence of typical plaque psoriasis outside palms and soles at both screening visitand Day 1.

  • Deemed by the investigator to be a candidate for phototherapy or systemic therapy.

  • Failed to respond to, or intolerant of ≥ 1 topical therapy.

Inclusion Criteria for Genital Psoriasis

  • Men and women diagnosed with stable plaque psoriasis with involvement of the genitalarea for at least 6 months or more. Stable psoriasis is defined as no morphologychanges or significant flares of disease activity in the opinion of theinvestigator.

  • Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scaleat both screening visit and Day 1.

  • Moderate-to-severe GenPs, defined as static Physician's Global Assessment ofGenitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day

  • Evidence of typical plaque psoriasis in a non-genital area at both screening visitand Day 1.

  • Deemed by the investigator to be a candidate for phototherapy or systemic therapy.

  • Failed to respond to, or intolerant of ≥ 1 topical therapy.

Exclusion

Key Exclusion Criteria:

Target Disease Exceptions

  • Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolatedpustules on palms or soles with or without erythema outside psoriatic plaques,guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 09, 2023
Estimated Completion Date:
April 25, 2025

Connect with a study center

  • Consultorios Reumatológicos Pampa

    Ciudad Autónoma Buenos Aires, B C1428DZF
    Argentina

    Active - Recruiting

  • Instituto de Neumonologia y Dermatologia

    Ciudad Autónoma Buenos Aires, B 1425
    Argentina

    Active - Recruiting

  • Local Institution - 0037

    Ciudad Autónoma Buenos Aires, B C1428DZF
    Argentina

    Site Not Available

  • Local Institution - 0043

    Ciudad Autónoma Buenos Aires, B 1425
    Argentina

    Site Not Available

  • Local Institution - 0034

    Ciudad Autonoma Buenos Aires, C C1425DKG
    Argentina

    Site Not Available

  • Psoriahue

    Ciudad Autonoma Buenos Aires, C C1425DKG
    Argentina

    Active - Recruiting

  • Instituto de Especialidades de la Salud Rosario

    Rosario, S 2000
    Argentina

    Active - Recruiting

  • Local Institution - 0042

    Rosario, S 2000
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • Psoriahue

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

  • Local Institution - 0058

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • S.K. Siddha Medicine Professional Corporation

    Newmarket, Ontario L3Y 5G8
    Canada

    Active - Recruiting

  • Local Institution - 0063

    Niagara Falls, Ontario L2E 6A6
    Canada

    Site Not Available

  • Canadian Dermatology Centre

    Toronto, Ontario M3B 0A7
    Canada

    Active - Recruiting

  • Local Institution - 0060

    Toronto, Ontario M3B 0A7
    Canada

    Site Not Available

  • Clinique de Dermatologie Rosemont

    Montreal, Quebec H1Y 3L1
    Canada

    Active - Recruiting

  • Innovaderm Research Inc. - Montreal

    Montreal, Quebec H2X 2V1
    Canada

    Active - Recruiting

  • Local Institution - 0054

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Local Institution - 0065

    Montreal, Quebec H1Y 3L1
    Canada

    Site Not Available

  • Clinique Espace D Dermatologie

    Québec, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Local Institution - 0059

    Québec, Quebec G1W 4R4
    Canada

    Site Not Available

  • Clinique de Dermatologie de St-Jérôme

    Saint-Jerome, Quebec J7Z 7E2
    Canada

    Active - Recruiting

  • Local Institution - 0061

    Saint-Jerome, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Local Institution - 0064

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Site Not Available

  • Skinsense Medical Research

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Active - Recruiting

  • Clinique Espace D Dermatologie

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Local Institution - 0028

    Berlin, BE 10789
    Germany

    Site Not Available

  • Local Institution - 0030

    Memmingen, BY 87700
    Germany

    Site Not Available

  • Local Institution - 0016

    Hamburg, HH 20246
    Germany

    Site Not Available

  • Local Institution - 0017

    Frankfurt am Main, Hesse 60590
    Germany

    Site Not Available

  • Local Institution - 0013

    Witten, Northwest 58453
    Germany

    Site Not Available

  • Local Institution - 0027

    Witten, Northwest 58453
    Germany

    Site Not Available

  • Local Institution - 0045

    Witten, Northwest 58453
    Germany

    Site Not Available

  • Local Institution - 0014

    Mainz, RP 55128
    Germany

    Site Not Available

  • Local Institution - 0040

    Brescia, BS 25123
    Italy

    Site Not Available

  • Local Institution - 0039

    Roma, RM 00133
    Italy

    Site Not Available

  • Local Institution - 0036

    Wroclaw, DS 50-566
    Poland

    Site Not Available

  • Local Institution - 0038

    Warsaw, Mazowieckie 02-962
    Poland

    Site Not Available

  • Local Institution - 0031

    Warszawa, Mazowieckie 02-507
    Poland

    Site Not Available

  • Local Institution - 0035

    Bialystok, PD 15-351
    Poland

    Site Not Available

  • Local Institution - 0032

    Rzeszow, PK 35-055
    Poland

    Site Not Available

  • Local Institution - 0024

    Madrid, M 28006
    Spain

    Site Not Available

  • Local Institution - 0018

    Córdoba, X 14004
    Spain

    Site Not Available

  • Local Institution - 0011

    Barcelona, 08041
    Spain

    Site Not Available

  • Local Institution - 0023

    Barcelona, 08041
    Spain

    Site Not Available

  • Local Institution - 0022

    Birmingham, Alabama 35233-3110
    United States

    Site Not Available

  • Whitaker Clinic of UAB Hospital

    Birmingham, Alabama 35233-3110
    United States

    Site Not Available

  • Local Institution - 0050

    Phoenix, Arizona 85006-2722
    United States

    Site Not Available

  • Medical Dermatology Specialists - Phoenix

    Phoenix, Arizona 85006-2722
    United States

    Active - Recruiting

  • First OC Dermatology - Fountain Valley

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Local Institution - 0015

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermatology Research Associates - Howard Sofen, MD

    Los Angeles, California 90045-3606
    United States

    Site Not Available

  • Local Institution - 0009

    Los Angeles, California 90045-3606
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Clinical Science Institute - Dermatology Institute

    Santa Monica, California 90404-2127
    United States

    Active - Recruiting

  • Local Institution - 0004

    Santa Monica, California 90404
    United States

    Site Not Available

  • Local Institution - 0048

    Santa Monica, California 90404-2127
    United States

    Site Not Available

  • Local Institution - 0051

    Rolling Meadows, Illinois 60008-3811
    United States

    Site Not Available

  • Endeavor Health Medical Group - Dermatology - Skokie

    Skokie, Illinois 60077-1049
    United States

    Active - Recruiting

  • Local Institution - 0057

    Skokie, Illinois 60077-1049
    United States

    Site Not Available

  • NorthShore Medical Group - Dermatology - Skokie

    Skokie, Illinois 60077-1049
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC (DFCRG)

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Local Institution - 0052

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Local Institution - 0053

    Plainfield, Indiana 46168-2792
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168-2792
    United States

    Active - Recruiting

  • Aesthetic and Dermatology Center

    Rockville, Maryland 20850-6243
    United States

    Site Not Available

  • Local Institution - 0029

    Rockville, Maryland 20850-6243
    United States

    Site Not Available

  • U.S. Dermatology Partners Rockville

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Henry Ford Medical Center

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan 48202-3141
    United States

    Active - Recruiting

  • Local Institution - 0012

    Detroit, Michigan 48202-3141
    United States

    Site Not Available

  • Local Institution - 0005

    East Windsor, New Jersey 08520-2505
    United States

    Site Not Available

  • Schweiger Dermatology Group - East Windsor - Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520-2505
    United States

    Active - Recruiting

  • Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520-2505
    United States

    Site Not Available

  • Icahn School Of Medicine At Mount Sinai

    New York, New York 10003
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai-Department of Dermatology

    New York, New York 10003
    United States

    Active - Recruiting

  • Local Institution - 0002

    New York, New York 10003
    United States

    Site Not Available

  • Local Institution - 0008

    New York, New York 10075
    United States

    Site Not Available

  • Local Institution - 0044

    New York, New York 10075-0337
    United States

    Site Not Available

  • Local Institution - 0049

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0062

    New York, New York 10128
    United States

    Site Not Available

  • OptiSkin Medical

    New York, New York 10128
    United States

    Active - Recruiting

  • Sadick Dermatology

    New York, New York 10075
    United States

    Active - Recruiting

  • Local Institution - 0001

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Local Institution - 0046

    Winston-Salem, North Carolina 27104-3520
    United States

    Site Not Available

  • Wake Forest University - Wake Forest School of Medicine - Center for Dermatology Research

    Winston-Salem, North Carolina 27104-3520
    United States

    Site Not Available

  • Wake Forest University School Of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Local Institution - 0066

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Optima Research - Boardman

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Apex Clinical Research Center, LLC

    Mayfield Heights, Ohio 44124-4005
    United States

    Active - Recruiting

  • Apex Dermatology - Mayfield Heights

    Mayfield Heights, Ohio 44124-4005
    United States

    Active - Recruiting

  • Local Institution - 0055

    Mayfield Heights, Ohio 44124-4005
    United States

    Site Not Available

  • Local Institution - 0021

    Portland, Oregon 97223-6683
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223-6683
    United States

    Site Not Available

  • Local Institution - 0056

    Pittsburgh, Pennsylvania 15213-3403
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania 15213-3403
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center - St. Margaret Dermatology

    Pittsburgh, Pennsylvania 15213-3403
    United States

    Site Not Available

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Local Institution - 0003

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Center for Clinical Studies - Texas Medical Center

    Houston, Texas 77004-8098
    United States

    Active - Recruiting

  • Center for Clinical Studies-TMC

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Local Institution - 0010

    Houston, Texas 77004
    United States

    Site Not Available

  • Local Institution - 0047

    Houston, Texas 77004-8098
    United States

    Site Not Available

  • Local Institution - 0007

    Norfolk, Virginia 23502-3933
    United States

    Site Not Available

  • Local Institution - 0019

    Norfolk, Virginia 23502-3933
    United States

    Site Not Available

  • Virginia Clinical Research

    Norfolk, Virginia 23502-3933
    United States

    Active - Recruiting

  • Frontier Dermatology

    Mill Creek, Washington 98012-1797
    United States

    Active - Recruiting

  • Local Institution - 0033

    Mill Creek, Washington 98012-1797
    United States

    Site Not Available

  • North Sound Dermatology - Mill Creek

    Mill Creek, Washington 98012-1797
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.