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RECRUITING

NCT06979453

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2025-12-03

Completion Date

2034-08-12

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Plaque Psoriasis

Interventions

DRUG

Deucravacitinib

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

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.

Locations (116)

Local Institution - 0261

Birmingham, Alabama, United States

Local Institution - 0041

Birmingham, Alabama, United States

Local Institution - 0053

Phoenix, Arizona, United States

Local Institution - 0025

Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Northridge Clinical Trials

Northridge, California, United States

Local Institution - 0077

Sacramento, California, United States

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Walnut Creek, California, United States

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States

Local Institution - 0021

Clearwater, Florida, United States

Life Clinical Trials

Margate, Florida, United States

Skin Research of South Florida

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research

Tampa, Florida, United States

Dermatology Affiliates Research Institute

Atlanta, Georgia, United States

Advanced Medical Research, PC.

Sandy Springs, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Local Institution - 0262

Murray, Kentucky, United States

Local Institution - 0202

Metairie, Louisiana, United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, United States

Local Institution - 0095

Detroit, Michigan, United States

Local Institution - 0233

Columbia, Missouri, United States

Local Institution - 0266

Lee's Summit, Missouri, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

Local Institution - 0166

The Bronx, New York, United States

Hickory Dermatology Research Center

Hickory, North Carolina, United States

Apex Clinical Research Center - Canton

Canton, Ohio, United States

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Paddington Testing Company

Philadelphia, Pennsylvania, United States

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States

Belle Meade Dermatology Research

Nashville, Tennessee, United States

Local Institution - 0268

Austin, Texas, United States

Local Institution - 0267

Cedar Park, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Local Institution - 0045

Norfolk, Virginia, United States

Frontier Derm Partners

Mill Creek, Washington, United States

Local Institution - 0264

Spokane, Washington, United States

Local Institution - 0115

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0119

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0149

Buenos Aires, Argentina

Local Institution - 0221

Buenos Aires, Argentina

Local Institution - 0250

Buenos Aires, Argentina

Local Institution - 0154

Buenos Aires, Argentina

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0210

Brussels, Bruxelles-Capitale, Région de, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

Local Institution - 0137

Salvador, Estado de Bahia, Brazil

Local Institution - 0182

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0136

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0140

Barretos, São Paulo, Brazil

Local Institution - 0163

Ribeirão Preto, São Paulo, Brazil

Local Institution - 0241

Edmonton, Alberta, Canada

Local Institution - 0164

Winnipeg, Manitoba, Canada

Skincare Studio

St. John's, Newfoundland and Labrador, Canada

DermEffects

London, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

AvantDerm

Toronto, Ontario, Canada

Local Institution - 0240

Toronto, Ontario, Canada

Local Institution - 0142

Montreal, Quebec, Canada

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, China

Local Institution - 0222

Beijing, Beijing Municipality, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

The Affiliated Hospital of Hebei University of Engineering

Handan, Hebei, China

Local Institution - 0227

Zhengzhou, Henan, China

Hunan Children's Hospital

Changsha, Hunan, China

Local Institution - 0265

Jinan, Shandong, China

Local Institution - 0131

Shanghai, Shanghai Municipality, China

Local Institution - 0228

Chengdu, Sichuan, China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Local Institution - 0225

Medellín, Antioquia, Colombia

Local Institution - 0124

Medellín, Antioquia, Colombia

Local Institution - 0167

Barranquilla, Atlántico, Colombia

Local Institution - 0125

Bogota, Cundinamarca, Colombia

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, Hungary

Clinexpert Kft.

Budapest, Pest County, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

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

Roma, Italy

Local Institution - 0238

Zapopan, Jalisco, Mexico

Local Institution - 0253

Mexico City, Mexico City, Mexico

Local Institution - 0155

Monterrey, Nuevo León, Mexico

Local Institution - 0259

Chihuahua City, Mexico

Local Institution - 0257

Mérida, Mexico

Local Institution - 0258

Toluca, Mexico

Local Institution - 0096

Veracruz, Mexico

Local Institution - 0177

Lublin, Lublin Voivodeship, Poland

FutureMeds - Targowek

Warsaw, Masovian Voivodeship, Poland

SPECDERM Poznanska sp.j.

Bialystok, Podlaskie Voivodeship, Poland

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

Lodz, Poland

ETYKA Osrodek Badan Klinicznych

Olsztyn, Poland

Klinika Ambroziak Dermatologia

Warsaw, Poland

Royalderm Agnieszka Nawrocka

Warsaw, Poland

Local Institution - 0254

Bayamón, Puerto Rico

Local Institution - 0008

Caguas, Puerto Rico

Local Institution - 0012

San Juan, Puerto Rico

Local Institution - 0174

Bucharest, București, Romania

Lotus-Med Tunari

Bucharest, București, Romania

Local Institution - 0213

Bucharest, București, Romania

Policlinica Providența

Iași, Romania

Centrul de Medicina de Familie

Iași, Romania

New Derm Clinical SRL

Timișoara, Romania

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Grupo Dermatológico y Estético Pedro Jaén S.A

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

CHUS - Hospital Clinico Universitario

Santiago de Compostela, Spain

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (116)