Recruiting
Phase 3

Deucravacitinib

Sponsor:

Bristol-Myers Squibb

Code:

NCT06979453

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Deucravacitinib

Placebo

Study Details

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

Study ID

NCT06979453

Start date

Dec 3, 2025

Status verified date

Sep, 2026

Completion date

Aug 12, 2034

Anticipated

Primary completion date

Oct 12, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

366 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Administration of Deucravacitinib

placebo comparator: Placebo

Interventions

Deucravacitinib

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) [ Time Frame: 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 [ Time Frame: At week 16 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Center For Dermatology Clinical Research, Inc.

Recruiting

Fremont, California, United States, 94538

Contacts

Sunil Dhawan, Site 0090

510-599-4750

Dermatology Research Associates

Recruiting

Los Angeles, California, United States, 90045

Contacts

Howard Sofen, Site 0006

310-337-7171

Northridge Clinical Trials

Recruiting

Northridge, California, United States, 91325

Contacts

Navid Ezra, Site 0214

818-350-7483

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Michael Wang, Site 0243

507-261-3758

Paradigm Clinical Research, LLC

Recruiting

Wheat Ridge, Colorado, United States, 80033

Contacts

Kimberly Neyman, Site 0231

303-463-1947

Life Clinical Trials

Recruiting

Margate, Florida, United States, 33063

Contacts

Eli Saleeby, Site 0185

954-849-0902

Skin Research of South Florida

Recruiting

Miami, Florida, United States, 33173

Contacts

Giovanna Ciocca, Site 0043

305-707-9852

Wellness Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

David Rodriguez, Site 0014

786-483-7856

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

Recruiting

Tampa, Florida, United States, 33607

Contacts

Stephen Lockwood, Site 0070

813-948-7550

USF Health

Recruiting

Tampa, Florida, United States, 33612

Contacts

Sharon Albers, Site 0171

813-974-4381

Dermatology Affiliates Research Institute

Recruiting

Atlanta, Georgia, United States, 30305

Contacts

Adebayo Akinsola, Site 0244

770-733-1077

Advanced Medical Research, PC.

Recruiting

Sandy Springs, Georgia, United States, 30328

Contacts

Jamie Weisman, Site 0072

404-939-9220

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Scott Fretzin, Site 0003

317-516-5030

Kentucky Advanced Medical Research LLC

Recruiting

Murray, Kentucky, United States, 42071

Dermatology and Skin Cancer Specialists, LLC

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Benjamin Lockshin, Site 0061

301-355-3183

Kuchnir Dermatology & Dermatologic Surgery

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Shiu-Chung Au, Site 0220

000-000-0000

C.S. Mott Clinical Research Center (CRC)

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Geoffrey Potts, Site 0095

248-581-5243

Henry Ford Medical Center

Recruiting

Detroit, Michigan, United States, 48202-3141

Contacts

Linda Stein Gold, Site 0065

248-884-5356

Dermatology and Skin Cancer Center

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Mark Fleischman, Site 0266

913-451-7546

JDR Dermatology Research

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

James Del Rosso, Site 0052

702-596-6137

Apex Clinical Research Center - Canton

Recruiting

Canton, Ohio, United States, 44716

Contacts

Jorge Garcia-Zuazaga, Site 0251

14404404430440

Apex Clinical Research Center

Recruiting

Lorain, Ohio, United States, 44053

Apex Clinical Research Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Brian Moore, Site 0055

440-940-2739

Paddington Testing Company

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Contacts

Jennifer Parish, Site 0073

215-563-7330

ObjectiveHealth - Goodlettsville Dermatology Research

Recruiting

Goodlettsville, Tennessee, United States, 37072

Contacts

Keith Loven, Site 0235

615-241-2820

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Contacts

John Browning, Site 0033

210-704-4037

Frontier Derm Partners

Recruiting

Mill Creek, Washington, United States, 98012

Contacts

Eingun Song, Site 0071

425-275-4404

Alberta Dermasurgery Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1C3

Contacts

Jaggi Rao, Site 0241

587-487-0187

Skincare Studio

Recruiting

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

Contacts

Tracey Brown-Maher, Site 0242

709-728-1563

DermEffects

Recruiting

London, Ontario, Canada, N6H 5L5

Contacts

Wei Jing Loo, Site 0143

2269197887

The Centre for Dermatology

Recruiting

Richmond Hill, Ontario, Canada, L4B 1A5

Contacts

Mani Raman, Site 0144

905-889-2005

AvantDerm

Recruiting

Toronto, Ontario, Canada, M5A 3R6

Contacts

Davindra Singh, Site 0156

(416) 869-3376

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-03.