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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT06979453

Run by

Bristol-Myers Squibb

People needed

366

Starts

2025-12-03

Expected to finish

2034-08-12

Last updated by the study team

2026-07-14

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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 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.

Where it is running

• Paddington Testing Company — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States (enrolling)
• Apex Clinical Research Center - Canton — Canton, Ohio, United States (enrolling)
• Apex Clinical Research Center — Mayfield Heights, Ohio, United States (enrolling)
• ObjectiveHealth - Goodlettsville Dermatology Research — Goodlettsville, Tennessee, United States (enrolling)
• Northridge Clinical Trials — Northridge, California, United States (enrolling)
• Henry Ford Medical Center — Detroit, Michigan, United States (enrolling)
• JDR Dermatology Research — Las Vegas, Nevada, United States (enrolling)
• Paradigm Clinical Research, LLC — Wheat Ridge, Colorado, United States (enrolling)
• Apex Clinical Research Center — Lorain, Ohio, United States (enrolling)
• Dermatology Research Associates — Los Angeles, California, United States (enrolling)
• Skin Research of South Florida — Miami, Florida, United States (enrolling)
• Wellness Clinical Research — Miami Lakes, Florida, United States (enrolling)
• MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research — Tampa, Florida, United States (enrolling)
• USF Health — Tampa, Florida, United States (enrolling)
• Dermatology Affiliates Research Institute — Atlanta, Georgia, United States (enrolling)
• Advanced Medical Research, PC. — Sandy Springs, Georgia, United States (enrolling)
• Golden State Dermatology - Walnut Creek - Ygnacio Valley Road — Walnut Creek, California, United States (enrolling)
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (enrolling)
• Kentucky Advanced Medical Research LLC — Murray, Kentucky, United States (enrolling)
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (enrolling)
• Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States (enrolling)
• Kuchnir Dermatology & Dermatologic Surgery — Milford, Massachusetts, United States (enrolling)
• Life Clinical Trials — Margate, Florida, United States (enrolling)
• Frontier Derm Partners — Mill Creek, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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