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

RecruitingPhase 3

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

Who can join

Ages 12 to 17 · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 366 · Started: Dec 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06979453

Locations in the U.S.

AlabamaLocal Institution - 0041, Birmingham (Not yet recruiting)
Local Institution - 0261, Birmingham (Not yet recruiting)
CaliforniaLocal Institution - 0025, Fountain Valley (Not yet recruiting)
Center For Dermatology Clinical Research, Inc., Fremont
Dermatology Research Associates, Los Angeles
Northridge Clinical Trials, Northridge
Local Institution - 0077, Sacramento (Not yet recruiting)
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road, Walnut Creek
ColoradoParadigm Clinical Research, LLC, Wheat Ridge
FloridaLocal Institution - 0021, Clearwater (Not yet recruiting)
Life Clinical Trials, Margate
Skin Research of South Florida, Miami
Wellness Clinical Research, Miami Lakes
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research, Tampa
USF Health, Tampa
GeorgiaDermatology Affiliates Research Institute, Atlanta
Advanced Medical Research, PC., Sandy Springs
IdahoLocal Institution - 0271, Ammon (Not yet recruiting)
IndianaDawes Fretzin Clinical Research Group, LLC, Indianapolis
KentuckyKentucky Advanced Medical Research LLC, Murray
LouisianaLocal Institution - 0202, Metairie (Not yet recruiting)
MarylandDermatology and Skin Cancer Specialists, LLC, Rockville
MassachusettsKuchnir Dermatology & Dermatologic Surgery, Milford
MichiganC.S. Mott Clinical Research Center (CRC), Detroit
Henry Ford Medical Center, Detroit
MissouriLocal Institution - 0233, Columbia (Not yet recruiting)
Local Institution - 0278, Columbia (Not yet recruiting)
Dermatology and Skin Cancer Center, Lee's Summit
NevadaJDR Dermatology Research, Las Vegas
New JerseyLocal Institution - 0283, Clifton (Not yet recruiting)
Local Institution - 0281, Robbinsville (Not yet recruiting)
New YorkLocal Institution - 0273, Brooklyn (Not yet recruiting)
Local Institution - 0205, New York (Not yet recruiting)
Local Institution - 0166, The Bronx (Not yet recruiting)
OhioApex Clinical Research Center - Canton, Canton
Apex Clinical Research Center, Lorain
Apex Clinical Research Center, Mayfield Heights
PennsylvaniaPaddington Testing Company, Philadelphia
TennesseeObjectiveHealth - Goodlettsville Dermatology Research, Goodlettsville
TexasTexas Dermatology and Laser Specialists, San Antonio
Local Institution - 0280, Southlake (Not yet recruiting)
VirginiaLocal Institution - 0045, Norfolk (Not yet recruiting)
WashingtonFrontier Derm Partners, Mill Creek
Local Institution - 0264, Spokane (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.