A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
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)
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) — 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 — At week 16
Trial sites (132)
Facility
City
Region
Status
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.
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.
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