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Clinical Trials in China / NCT06979453
Recruiting Phase 3

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

NCT06979453 · tracked via the Priya Life Science China tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2025-12-03
Last updated
2026-09-03

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

DeucravacitinibPlacebo

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (132)

FacilityCityRegionStatus
Local Institution - 0261 Birmingham Alabama Not Yet Recruiting
Local Institution - 0041 Birmingham Alabama Not Yet Recruiting
Local Institution - 0053 Phoenix Arizona Active Not Recruiting
Local Institution - 0025 Fountain Valley California Not Yet Recruiting
Center For Dermatology Clinical Research, Inc. Fremont California Recruiting
Dermatology Research Associates Los Angeles California Recruiting
Northridge Clinical Trials Northridge California Recruiting
Local Institution - 0077 Sacramento California Not Yet Recruiting
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road Walnut Creek California Recruiting
Paradigm Clinical Research, LLC Wheat Ridge Colorado Recruiting
Local Institution - 0021 Clearwater Florida Not Yet Recruiting
Life Clinical Trials Margate Florida Recruiting
Skin Research of South Florida Miami Florida Recruiting
Wellness Clinical Research Miami Lakes Florida Recruiting
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research Tampa Florida Recruiting
USF Health Tampa Florida Recruiting
Dermatology Affiliates Research Institute Atlanta Georgia Recruiting
Advanced Medical Research, PC. Sandy Springs Georgia Recruiting
Local Institution - 0271 Ammon Idaho Not Yet Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
Kentucky Advanced Medical Research LLC Murray Kentucky Recruiting
Local Institution - 0202 Metairie Louisiana Not Yet Recruiting
Dermatology and Skin Cancer Specialists, LLC Rockville Maryland Recruiting
Kuchnir Dermatology & Dermatologic Surgery Milford Massachusetts Recruiting
C.S. Mott Clinical Research Center (CRC) Detroit Michigan Recruiting
Henry Ford Medical Center Detroit Michigan Recruiting
Local Institution - 0233 Columbia Missouri Not Yet Recruiting
Local Institution - 0278 Columbia Missouri Not Yet Recruiting
Dermatology and Skin Cancer Center Lee's Summit Missouri Recruiting
JDR Dermatology Research Las Vegas Nevada Recruiting
Local Institution - 0283 Clifton New Jersey Not Yet Recruiting
Local Institution - 0281 Robbinsville New Jersey Not Yet Recruiting
Local Institution - 0273 Brooklyn New York Not Yet Recruiting
Local Institution - 0205 New York New York Not Yet Recruiting
Local Institution - 0166 The Bronx New York Not Yet Recruiting
Local Institution - 0234 Hickory North Carolina Completed
Apex Clinical Research Center - Canton Canton Ohio Recruiting
Apex Clinical Research Center Lorain Ohio Recruiting
Apex Clinical Research Center Mayfield Heights Ohio Recruiting
Paddington Testing Company Philadelphia Pennsylvania Recruiting

+ 92 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06979453 on ClinicalTrials.gov ↗ ← All trials in China