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

NCT ID: NCT06979453

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2034-08-12

Brief Summary

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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

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Administration of Deucravacitinib

Group Type ACTIVE_COMPARATOR

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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Deucravacitinib

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-986165

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0261

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0041

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0053

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 0025

Fountain Valley, California, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0090

Fremont, California, United States

Site Status NOT_YET_RECRUITING

Dermatology Research Associates

Los Angeles, California, United States

Site Status RECRUITING

Northridge Clinical Trials

Northridge, California, United States

Site Status RECRUITING

Local Institution - 0077

Sacramento, California, United States

Site Status NOT_YET_RECRUITING

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Walnut Creek, California, United States

Site Status RECRUITING

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States

Site Status RECRUITING

Local Institution - 0021

Clearwater, Florida, United States

Site Status NOT_YET_RECRUITING

Life Clinical Trials

Margate, Florida, United States

Site Status RECRUITING

Skin Research of South Florida

Miami, Florida, United States

Site Status RECRUITING

Wellness Clinical Research

Miami Lakes, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

Dermatology Affiliates Research Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Advanced Medical Research, PC.

Sandy Springs, Georgia, United States

Site Status RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status RECRUITING

Local Institution - 0262

Murray, Kentucky, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0202

Metairie, Louisiana, United States

Site Status NOT_YET_RECRUITING

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Site Status RECRUITING

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, United States

Site Status RECRUITING

Local Institution - 0095

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0233

Columbia, Missouri, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0266

Lee's Summit, Missouri, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0052

Las Vegas, Nevada, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0166

The Bronx, New York, United States

Site Status NOT_YET_RECRUITING

Hickory Dermatology Research Center

Hickory, North Carolina, United States

Site Status RECRUITING

Apex Clinical Research Center - Canton

Canton, Ohio, United States

Site Status RECRUITING

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Site Status RECRUITING

Paddington Testing Company

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States

Site Status RECRUITING

Belle Meade Dermatology Research

Nashville, Tennessee, United States

Site Status RECRUITING

Local Institution - 0268

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0267

Cedar Park, Texas, United States

Site Status NOT_YET_RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status RECRUITING

Local Institution - 0045

Norfolk, Virginia, United States

Site Status NOT_YET_RECRUITING

Frontier Derm Partners

Mill Creek, Washington, United States

Site Status RECRUITING

Local Institution - 0264

Spokane, Washington, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0115

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0119

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0149

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0221

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0250

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Local Institution - 0154

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

Site Status RECRUITING

Local Institution - 0210

Brussels, Bruxelles-Capitale, Région de, Belgium

Site Status WITHDRAWN

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, , Belgium

Site Status RECRUITING

Local Institution - 0137

Salvador, Estado de Bahia, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0182

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0136

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0140

Barretos, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0163

Ribeirão Preto, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0241

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Local Institution - 0164

Winnipeg, Manitoba, Canada

Site Status NOT_YET_RECRUITING

Skincare Studio

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

DermEffects

London, Ontario, Canada

Site Status RECRUITING

The Centre for Dermatology

Richmond Hill, Ontario, Canada

Site Status RECRUITING

AvantDerm

Toronto, Ontario, Canada

Site Status RECRUITING

Local Institution - 0240

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Local Institution - 0142

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Local Institution - 0222

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Local Institution - 0226

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Local Institution - 0255

Handan, Hebei, China

Site Status NOT_YET_RECRUITING

Local Institution - 0227

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Local Institution - 0265

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Local Institution - 0131

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Local Institution - 0228

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Local Institution - 0224

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Local Institution - 0225

Medellín, Antioquia, Colombia

Site Status NOT_YET_RECRUITING

Local Institution - 0124

Medellín, Antioquia, Colombia

Site Status NOT_YET_RECRUITING

Local Institution - 0167

Barranquilla, Atlántico, Colombia

Site Status NOT_YET_RECRUITING

Local Institution - 0125

Bogota, Cundinamarca, Colombia

Site Status NOT_YET_RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, , Germany

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status RECRUITING

Universitaetsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Local Institution - 0203

Szeged, Csongrád megye, Hungary

Site Status NOT_YET_RECRUITING

Clinexpert Kft.

Budapest, Pest County, Hungary

Site Status RECRUITING

Local Institution - 0238

Zapopan, Jalisco, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0253

Mexico City, Mexico City, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0155

Monterrey, Nuevo León, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0259

Chihuahua City, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0257

Mérida, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0237

Puebla City, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0258

Toluca, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0096

Veracruz, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0177

Lublin, Lublin Voivodeship, Poland

Site Status WITHDRAWN

FutureMeds - Targowek

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

SPECDERM Poznanska sp.j.

Bialystok, Podlaskie Voivodeship, Poland

Site Status RECRUITING

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

Lodz, , Poland

Site Status RECRUITING

ETYKA Osrodek Badan Klinicznych

Olsztyn, , Poland

Site Status RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, , Poland

Site Status RECRUITING

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Site Status RECRUITING

Local Institution - 0254

Bayamón, , Puerto Rico

Site Status NOT_YET_RECRUITING

Local Institution - 0008

Caguas, , Puerto Rico

Site Status NOT_YET_RECRUITING

Local Institution - 0012

San Juan, , Puerto Rico

Site Status NOT_YET_RECRUITING

Local Institution - 0174

Bucharest, București, Romania

Site Status WITHDRAWN

Local Institution - 0249

Bucharest, București, Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0213

Bucharest, București, Romania

Site Status WITHDRAWN

Policlinica Providența

Iași, , Romania

Site Status RECRUITING

Centrul de Medicina de Familie

Iași, , Romania

Site Status RECRUITING

New Derm Clinical SRL

Timișoara, , Romania

Site Status RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Site Status RECRUITING

Grupo Pedro Jaén

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

CHUS - Hospital Clinico Universitario

Santiago de Compostela, , Spain

Site Status RECRUITING

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Site Status RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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United States Argentina Belgium Brazil Canada China Colombia Germany Hungary Mexico Poland Puerto Rico Romania Spain Taiwan

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Site 0261

Role: primary

Site 0041

Role: primary

Site 0025

Role: primary

Site 0090

Role: primary

Howard Sofen, Site 0006

Role: primary

310-337-7171

Navid Ezra, Site 0214

Role: primary

818-350-7483

Site 0077

Role: primary

Michael Wang, Site 0243

Role: primary

507-261-3758

Kimberly Neyman, Site 0231

Role: primary

303-463-1947

Site 0021

Role: primary

Eli Saleeby, Site 0185

Role: primary

954-849-0902

Giovanna Ciocca, Site 0043

Role: primary

305-707-9852

David Rodriguez, Site 0014

Role: primary

786-483-7856

Stephen Lockwood, Site 0070

Role: primary

813-948-7550

Anita Shetty, Site 0244

Role: primary

404-816-7900

Jamie Weisman, Site 0072

Role: primary

404-939-9220

Scott Fretzin, Site 0003

Role: primary

317-516-5030

Site 0262

Role: primary

Site 0202

Role: primary

Benjamin Lockshin, Site 0061

Role: primary

301-355-3183

Shiu-Chung Au, Site 0220

Role: primary

000-000-0000

Site 0095

Role: primary

Site 0233

Role: primary

Site 0266

Role: primary

Site 0052

Role: primary

Site 0166

Role: primary

Jake Turrentine, Site 0234

Role: primary

828-638-4626

Jorge Garcia-Zuazaga, Site 0251

Role: primary

14404404430440

Jorge Garcia-Zuazaga, Site 0055

Role: primary

14404404430440

Jennifer Parish, Site 0073

Role: primary

215-563-7330

Keith Loven, Site 0235

Role: primary

615-241-2820

Ashley Matthews, Site 0248

Role: primary

615-216-5893

Site 0268

Role: primary

Site 0267

Role: primary

John Browning, Site 0033

Role: primary

210-704-4037

Site 0045

Role: primary

Eingun Song, Site 0071

Role: primary

425-275-4404

Site 0264

Role: primary

Site 0115

Role: primary

Site 0119

Role: primary

Site 0149

Role: primary

Site 0221

Role: primary

Site 0250

Role: primary

Site 0154

Role: primary

Pierre-Dominique Ghislain, Site 0209

Role: primary

3227641472

Sofie De Schepper, Site 0207

Role: primary

003293322287

ARJEN NIKKELS, Site 0208

Role: primary

+3243237232

Site 0137

Role: primary

Site 0182

Role: primary

Site 0136

Role: primary

Site 0140

Role: primary

Site 0163

Role: primary

Site 0241

Role: primary

Site 0164

Role: primary

Tracey Brown-Maher, Site 0242

Role: primary

709-728-1563

Wei Jing Loo, Site 0143

Role: primary

2269197887

Mani Raman, Site 0144

Role: primary

905-889-2005

Davindra Singh, Site 0156

Role: primary

(416) 869-3376

Site 0240

Role: primary

Site 0142

Role: primary

Zigang Xu, Site 0134

Role: primary

13370115021

Site 0222

Role: primary

Site 0226

Role: primary

Site 0255

Role: primary

Site 0227

Role: primary

Site 0265

Role: primary

Site 0131

Role: primary

Site 0228

Role: primary

Site 0224

Role: primary

Site 0225

Role: primary

Site 0124

Role: primary

Site 0167

Role: primary

Site 0125

Role: primary

Nina Magnolo, Site 0195

Role: primary

0049-251-8356558

Sven Quist, Site 0194

Role: primary

00496131 9722360

Sonja Molin, Site 0211

Role: primary

030450618343

Susanne Abraham, Site 0204

Role: primary

+493514583401

Michael Sticherling, Site 0193

Role: primary

+4991318533851

Site 0203

Role: primary

Dorottya Asboth, Site 0153

Role: primary

+3612108139

Site 0238

Role: primary

Site 0253

Role: primary

Site 0155

Role: primary

Site 0259

Role: primary

Site 0257

Role: primary

Site 0237

Role: primary

Site 0258

Role: primary

Site 0096

Role: primary

Patrycja Wislinska, Site 0212

Role: primary

48722266055

Maria Poznanska, Site 0103

Role: primary

0048883251755

Andrzej Kaszuba, Site 0106

Role: primary

0048603544222

Agata Maciejewska - Radomska, Site 0101

Role: primary

+48895134629

Monika Kalowska, Site 0178

Role: primary

+48601986646

Witold Owczarek, Site 0102

Role: primary

00 48 601 316 460

Site 0254

Role: primary

Site 0008

Role: primary

Site 0012

Role: primary

Site 0249

Role: primary

Elena Crihan, Site 0181

Role: primary

0040746743561

Petronela Cozma, Site 0173

Role: primary

0743813380

Stefania Avram, Site 0200

Role: primary

40752976613

Asuncion Vicente Villa, Site 0218

Role: primary

936009733(ext.70034)

Alvaro Gonzalez-Cantero, Site 0196

Role: primary

+34620408898

Raquel Rivera-Diaz, Site 0216

Role: primary

34917792260

Isabel Rodríguez Blanco, Site 0197

Role: primary

0034981956011

Ji-Chen Ho, Site 0114

Role: primary

886 77317123 x2426

Chien-Hui Hong, Site 0201

Role: primary

886-7-3422121x74300

Tsen-Fang Tsai, Site 0113

Role: primary

886223123456

Yu-Huei Huang, Site 0112

Role: primary

886975360157

Related Links

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Other Identifiers

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2023-506296-97

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1289-8030

Identifier Type: OTHER

Identifier Source: secondary_id

IM011-1128

Identifier Type: -

Identifier Source: org_study_id

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