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

NCT06979453 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: IM011-11282023-506296-97U1111-1289-8030
• Study Type: interventional
• Target: 366
• Locations: 16 countries
• Sites: 120

Brief 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

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Rash; Itch; Teen; Dermatology; Derm; POETYK-PsO-Peds-1

Outcome Measures

Primary Outcomes (2)

• Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)

  At week 16

• Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline

  At week 16

Secondary Outcomes (18)

• Number of participants achieving at least 90% improvement in PASI (PASI 90)

  At week 16

• Change from baseline in PASI

  At week 16

• Change from baseline in body surface area (BSA) involvement

  At week 16

• Change from baseline in worst itch numeric rating scale (WI-NRS)

  At week 16

• Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)

  At week 16

Study Arms (2)

Administration of Deucravacitinib

ACTIVE COMPARATOR

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Administration of Deucravacitinib

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (120)

Local Institution - 0261

Birmingham, Alabama, 35203, United States

NOT YET RECRUITING

Local Institution - 0041

Birmingham, Alabama, 35243, United States

NOT YET RECRUITING

Local Institution - 0053

Phoenix, Arizona, 85006, United States

ACTIVE NOT RECRUITING

Local Institution - 0025

Fountain Valley, California, 92708, United States

NOT YET RECRUITING

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

RECRUITING

Dermatology Research Associates

Los Angeles, California, 90045, United States

RECRUITING

Northridge Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Local Institution - 0077

Sacramento, California, 95814, United States

NOT YET RECRUITING

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Walnut Creek, California, 94598, United States

RECRUITING

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, 80033, United States

RECRUITING

Local Institution - 0021

Clearwater, Florida, 33756, United States

NOT YET RECRUITING

Life Clinical Trials

Margate, Florida, 33063, United States

RECRUITING

Skin Research of South Florida

Miami, Florida, 33173, United States

RECRUITING

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

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

Tampa, Florida, 33607, United States

RECRUITING

USF Health

Tampa, Florida, 33612, United States

RECRUITING

Dermatology Affiliates Research Institute

Atlanta, Georgia, 30305, United States

RECRUITING

Advanced Medical Research, PC.

Sandy Springs, Georgia, 30328, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

Local Institution - 0262

Murray, Kentucky, 42071, United States

NOT YET RECRUITING

Local Institution - 0202

Metairie, Louisiana, 70001, United States

NOT YET RECRUITING

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850, United States

RECRUITING

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, 01757, United States

RECRUITING

Local Institution - 0095

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Local Institution - 0233

Columbia, Missouri, 65201, United States

NOT YET RECRUITING

Local Institution - 0266

Lee's Summit, Missouri, 64064, United States

NOT YET RECRUITING

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

RECRUITING

Local Institution - 0166

The Bronx, New York, 10467, United States

NOT YET RECRUITING

Local Institution - 0234

Hickory, North Carolina, 28602, United States

COMPLETED

Apex Clinical Research Center - Canton

Canton, Ohio, 44716, United States

RECRUITING

Local Institution - 0271

Columbus, Ohio, 43228, United States

NOT YET RECRUITING

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Paddington Testing Company

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

RECRUITING

Local Institution - 0248

Nashville, Tennessee, 37205, United States

COMPLETED

Local Institution - 0268

Austin, Texas, 78759, United States

NOT YET RECRUITING

Local Institution - 0267

Cedar Park, Texas, 78613, United States

NOT YET RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Local Institution - 0045

Norfolk, Virginia, 23502, United States

NOT YET RECRUITING

Frontier Derm Partners

Mill Creek, Washington, 98012, United States

RECRUITING

Local Institution - 0264

Spokane, Washington, 99204, United States

NOT YET RECRUITING

Local Institution - 0115

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina

NOT YET RECRUITING

Local Institution - 0119

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG, Argentina

NOT YET RECRUITING

Local Institution - 0149

Buenos Aires, 1012, Argentina

NOT YET RECRUITING

Local Institution - 0221

Buenos Aires, 1181, Argentina

NOT YET RECRUITING

Local Institution - 0250

Buenos Aires, 1425, Argentina

NOT YET RECRUITING

Local Institution - 0154

Buenos Aires, 1426, Argentina

NOT YET RECRUITING

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

RECRUITING

Local Institution - 0210

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

WITHDRAWN

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

RECRUITING

Local Institution - 0137

Salvador, Estado de Bahia, 41820-020, Brazil

NOT YET RECRUITING

Local Institution - 0182

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

NOT YET RECRUITING

Local Institution - 0136

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

NOT YET RECRUITING

Local Institution - 0140

Barretos, São Paulo, 14784400, Brazil

NOT YET RECRUITING

Local Institution - 0163

Ribeirão Preto, São Paulo, 14051-140, Brazil

NOT YET RECRUITING

Local Institution - 0170

São Paulo, 05403-000, Brazil

NOT YET RECRUITING

Alberta Dermasurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

RECRUITING

Local Institution - 0164

Winnipeg, Manitoba, R3C 0N2, Canada

NOT YET RECRUITING

Skincare Studio

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

RECRUITING

DermEffects

London, Ontario, N6H 5L5, Canada

RECRUITING

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

RECRUITING

AvantDerm

Toronto, Ontario, M5A 3R6, Canada

RECRUITING

Local Institution - 0240

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

Local Institution - 0142

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

RECRUITING

The Affiliated Hospital of Hebei University of Engineering

Handan, Hebei, 56029, China

RECRUITING

Local Institution - 0227

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

Local Institution - 0265

Jinan, Shandong, 250022, China

NOT YET RECRUITING

Local Institution - 0131

Shanghai, Shanghai Municipality, 200443, China

NOT YET RECRUITING

Local Institution - 0228

Chengdu, Sichuan, 610091, China

NOT YET RECRUITING

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

RECRUITING

Local Institution - 0225

Medellín, Antioquia, 050012, Colombia

NOT YET RECRUITING

Local Institution - 0124

Medellín, Antioquia, 50021, Colombia

NOT YET RECRUITING

Local Institution - 0167

Barranquilla, Atlántico, 080002, Colombia

NOT YET RECRUITING

Local Institution - 0125

Bogota, Cundinamarca, 111 411, Colombia

NOT YET RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, 55128, Germany

RECRUITING

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, 6720, Hungary

RECRUITING

Clinexpert Kft.

Budapest, Pest County, 1033, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

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

Roma, 00168, Italy

RECRUITING

Local Institution - 0238

Zapopan, Jalisco, 45190, Mexico

NOT YET RECRUITING

Local Institution - 0253

Mexico City, Mexico City, 06720, Mexico

NOT YET RECRUITING

Local Institution - 0155

Monterrey, Nuevo León, 64718, Mexico

NOT YET RECRUITING

Local Institution - 0259

Chihuahua City, 31217, Mexico

NOT YET RECRUITING

Local Institution - 0257

Mérida, 97070, Mexico

NOT YET RECRUITING

Local Institution - 0258

Toluca, 50010, Mexico

NOT YET RECRUITING

Local Institution - 0096

Veracruz, 91910, Mexico

NOT YET RECRUITING

Local Institution - 0177

Lublin, Lublin Voivodeship, 20-573, Poland

WITHDRAWN

FutureMeds - Targowek

Warsaw, Masovian Voivodeship, 03-291, Poland

RECRUITING

SPECDERM Poznanska sp.j.

Bialystok, Podlaskie Voivodeship, 15-375, Poland

RECRUITING

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

Lodz, 90-265, Poland

RECRUITING

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

RECRUITING

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

RECRUITING

Local Institution - 0254

Bayamón, 00960, Puerto Rico

NOT YET RECRUITING

Local Institution - 0008

Caguas, 00725, Puerto Rico

NOT YET RECRUITING

GCM Medical Group, PSC - Hato Rey Site

San Juan, 00917, Puerto Rico

RECRUITING

Local Institution - 0174

Bucharest, Bucharest, 020125, Romania

WITHDRAWN

Lotus-Med Tunari

Bucharest, Bucharest, 020528, Romania

RECRUITING

Local Institution - 0213

Bucharest, Bucharest, 30463, Romania

WITHDRAWN

Policlinica Providența

Iași, 700259, Romania

RECRUITING

Centrul de Medicina de Familie

Iași, 700556, Romania

RECRUITING

New Derm Clinical SRL

Timișoara, 300757, Romania

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

RECRUITING

Local Institution - 0198

Barcelona, Catalunya [Cataluña], 08041, Spain

NOT YET RECRUITING

Grupo Dermatológico y Estético Pedro Jaén S.A

Madrid, 28002, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

CHUS - Hospital Clinico Universitario

Santiago de Compostela, 15706, Spain

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psoriasis; Exanthema; Pruritus

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): October 12, 2029
• Study Completion (Estimated): August 12, 2034
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

BE (4); HU (3); AR (6); BR (6); US (41); TW (4); CN (10); PR (3); CO (4); ME (7); DE (5); ES (5); CA (8); PL (7); RO (6); IT (1)