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NCT06979453PHASE3Recruiting

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb

Start Date

12/3/2025

Completion Date

8/12/2034

Summary

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Eligibility Criteria

Age Range: 12 years to 17 years

Inclusion Criteria * Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1. iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1. \- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:. i) Is not an individual of childbearing potential (IOCBP). ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Exclusion Criteria * Participants must not weigh \< 30.0 kg at Screening and Day 1. * Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1. * Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1. * Participants must not have any untreated bacterial infection within 60 days prior to Day 1. * Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis). * Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions. * Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention. * Participants must not have had any prior exposure to deucravacitinib. * Participants must not have received any medication that is specifically prohibited. * Participants must not have a laboratory finding that is exclusionary. * Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study. * Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Deucravacitinib

OTHER

Placebo

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Conditions

Plaque Psoriasis

Locations

Local Institution - 0261

Birmingham, Alabama 35203

United States

Local Institution - 0041

Birmingham, Alabama 35243

United States

Local Institution - 0053

Phoenix, Arizona 85006

United States

Local Institution - 0025

Fountain Valley, California 92708

United States

Center For Dermatology Clinical Research, Inc.

Fremont, California 94538

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

Northridge Clinical Trials

Northridge, California 91325

United States

Local Institution - 0077

Sacramento, California 95814

United States

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Walnut Creek, California 94598

United States

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado 80033

United States

Local Institution - 0021

Clearwater, Florida 33756

United States

Life Clinical Trials

Margate, Florida 33063

United States

Skin Research of South Florida

Miami, Florida 33173

United States

Wellness Clinical Research

Miami Lakes, Florida 33016

United States

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

Tampa, Florida 33607

United States

USF Health

Tampa, Florida 33612

United States

Dermatology Affiliates Research Institute

Atlanta, Georgia 30305

United States

Advanced Medical Research, PC.

Sandy Springs, Georgia 30328

United States

Local Institution - 0271

Ammon, Idaho 83406

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

Kentucky Advanced Medical Research LLC

Murray, Kentucky 42071

United States

Local Institution - 0202

Metairie, Louisiana 70001

United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland 20850

United States

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts 01757

United States

Local Institution - 0095

Detroit, Michigan 48201

United States

Henry Ford Medical Center

Detroit, Michigan 48202-3141

United States

Local Institution - 0233

Columbia, Missouri 65201

United States

Local Institution - 0278

Columbia, Missouri 65212

United States

Local Institution - 0266

Lee's Summit, Missouri 64064

United States

JDR Dermatology Research

Las Vegas, Nevada 89148

United States

Local Institution - 0283

Clifton, New Jersey 07013

United States

Local Institution - 0281

Robbinsville, New Jersey 08691

United States

Local Institution - 0273

Brooklyn, New York 11203

United States

Local Institution - 0205

New York, New York 10075

United States

Local Institution - 0166

The Bronx, New York 10467

United States

Local Institution - 0234

Hickory, North Carolina 28602

United States

Apex Clinical Research Center - Canton

Canton, Ohio 44716

United States

Apex Clinical Research Center

Lorain, Ohio 44053

United States

Apex Clinical Research Center

Mayfield Heights, Ohio 44124

United States

Paddington Testing Company

Philadelphia, Pennsylvania 19103

United States

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee 37072

United States

Local Institution - 0248

Nashville, Tennessee 37205

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

United States

Local Institution - 0280

Southlake, Texas 76092

United States

Local Institution - 0045

Norfolk, Virginia 23502

United States

Frontier Derm Partners

Mill Creek, Washington 98012

United States

Local Institution - 0264

Spokane, Washington 99204

United States

Instituto de Neumonologia Y Dermatologia

Ciudad Autonoma de Buenos Aires, Buenos Aires 1425

Argentina

Psoriahue

Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG

Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province T4000AXL

Argentina

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, 1181

Argentina

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, 1425

Argentina

Derma Internacional

Buenos Aires, 1426

Argentina

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

Local Institution - 0210

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Local Institution - 0137

Salvador, Estado de Bahia 41820-020

Brazil

Local Institution - 0182

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul 90560-032

Brazil

Local Institution - 0140

Barretos, São Paulo 14784400

Brazil

Local Institution - 0163

Ribeirão Preto, São Paulo 14051-140

Brazil

Local Institution - 0170

São Paulo, 05403-000

Brazil

Alberta Dermasurgery Centre

Edmonton, Alberta T6G 1C3

Canada

Local Institution - 0164

Winnipeg, Manitoba R3C 0N2

Canada

Skincare Studio

St. John's, Newfoundland and Labrador A1E 1V4

Canada

DermEffects

London, Ontario N6H 5L5

Canada

The Centre for Dermatology

Richmond Hill, Ontario L4B 1A5

Canada

AvantDerm

Toronto, Ontario M5A 3R6

Canada

Local Institution - 0240

Toronto, Ontario M5G 1X8

Canada

Local Institution - 0142

Montreal, Quebec H3T 1C5

Canada

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality 100045

China

Peking University Third Hospital

Beijing, Beijing Municipality 100091

China

Guangdong Province Dermatology Hospital

Guangzhou, Guangdong 510018

China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong 518053

China

The Affiliated Hospital of Hebei University of Engineering

Handan, Hebei 56029

China

People's Hospital of Henan Province

Zhengzhou, Henan 450003

China

Hunan Children's Hospital

Changsha, Hunan 410007

China

Local Institution - 0265

Jinan, Shandong 250022

China

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality 200443

China

Local Institution - 0228

Chengdu, Sichuan 610091

China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang 310006

China

Local Institution - 0225

Medellín, Antioquia 050012

Colombia

Local Institution - 0124

Medellín, Antioquia 50021

Colombia

Local Institution - 0167

Barranquilla, Atlántico 080002

Colombia

Local Institution - 0125

Bogota, Cundinamarca 111 411

Colombia

Universitätsklinikum Münster

Münster, North Rhine-Westphalia 48149

Germany

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate 55128

Germany

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117

Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye 6720

Hungary

Clinexpert Kft.

Budapest, Pest County 1033

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032

Hungary

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, 00168

Italy

Local Institution - 0238

Zapopan, Jalisco 45190

Mexico

Local Institution - 0253

Mexico City, Mexico City 06720

Mexico

Local Institution - 0155

Monterrey, Nuevo León 64718

Mexico

Local Institution - 0259

Chihuahua City, 31217

Mexico

Local Institution - 0257

Mérida, 97070

Mexico

Local Institution - 0258

Toluca, 50010

Mexico

Local Institution - 0096

Veracruz, 91910

Mexico

Local Institution - 0177

Lublin, Lublin Voivodeship 20-573

Poland

FutureMeds - Targowek

Warsaw, Masovian Voivodeship 03-291

Poland

SPECDERM Poznanska sp.j.

Bialystok, Podlaskie Voivodeship 15-375

Poland

Local Institution - 0282

Gdansk, Pomeranian Voivodeship 80-546

Poland

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, 90-265

Poland

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117

Poland

Klinika Ambroziak Dermatologia

Warsaw, 02-953

Poland

Royalderm Agnieszka Nawrocka

Warsaw, 02-962

Poland

Local Institution - 0254

Bayamón, 00960

Puerto Rico

Local Institution - 0008

Caguas, 00725

Puerto Rico

GCM Medical Group, PSC - Hato Rey Site

San Juan, 00917

Puerto Rico

Local Institution - 0174

Bucharest, Bucharest 020125

Romania

Lotus-Med Tunari

Bucharest, Bucharest 020528

Romania

Local Institution - 0213

Bucharest, Bucharest 30463

Romania

Policlinica Providența

Iași, 700259

Romania

Centrul de Medicina de Familie

Iași, 700556

Romania

New Derm Clinical SRL

Timișoara, 300757

Romania

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona] 08950

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña] 08041

Spain

Grupo Dermatológico y Estético Pedro Jaén S.A

Madrid, 28002

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

CHUS - Hospital Clinico Universitario

Santiago de Compostela, 15706

Spain

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung 83301

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan