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

Recruiting · NCT06979453 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Psoriasis

Interventions studied

DeucravacitinibPlacebo

What this trial is about

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

Who can take part

Age range

12 Years to 17 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 24 US states.

Local Institution - 0261 - Birmingham, Alabama, United States
Local Institution - 0041 - Birmingham, Alabama, United States
Local Institution - 0053 - Phoenix, Arizona, United States
Local Institution - 0025 - Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc. - Fremont, California, United States
Dermatology Research Associates - Los Angeles, California, United States
Northridge Clinical Trials - Northridge, California, United States
Local Institution - 0077 - Sacramento, California, United States
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road - Walnut Creek, California, United States
Paradigm Clinical Research, LLC - Wheat Ridge, Colorado, United States
Local Institution - 0021 - Clearwater, Florida, United States
Life Clinical Trials - Margate, Florida, United States
Skin Research of South Florida - Miami, Florida, United States
Wellness Clinical Research - Miami Lakes, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research - Tampa, Florida, United States
USF Health - Tampa, Florida, United States
Dermatology Affiliates Research Institute - Atlanta, Georgia, United States
Advanced Medical Research, PC. - Sandy Springs, Georgia, United States
Local Institution - 0271 - Ammon, Idaho, United States
Dawes Fretzin Clinical Research Group, LLC - Indianapolis, Indiana, United States
Kentucky Advanced Medical Research LLC - Murray, Kentucky, United States
Local Institution - 0202 - Metairie, Louisiana, United States
Dermatology and Skin Cancer Specialists, LLC - Rockville, Maryland, United States
Kuchnir Dermatology & Dermatologic Surgery - Milford, Massachusetts, United States
C.S. Mott Clinical Research Center (CRC) - Detroit, Michigan, United States
Henry Ford Medical Center - Detroit, Michigan, United States
Local Institution - 0233 - Columbia, Missouri, United States
Local Institution - 0278 - Columbia, Missouri, United States
Dermatology and Skin Cancer Center - Lee's Summit, Missouri, United States
JDR Dermatology Research - Las Vegas, Nevada, United States
Local Institution - 0283 - Clifton, New Jersey, United States
Local Institution - 0281 - Robbinsville, New Jersey, United States
Local Institution - 0273 - Brooklyn, New York, United States
Local Institution - 0205 - New York, New York, United States
Local Institution - 0166 - The Bronx, New York, United States
Local Institution - 0234 - Hickory, North Carolina, United States
Apex Clinical Research Center - Canton - Canton, Ohio, United States
Apex Clinical Research Center - Lorain, Ohio, United States
Apex Clinical Research Center - Mayfield Heights, Ohio, United States
Paddington Testing Company - Philadelphia, Pennsylvania, United States
ObjectiveHealth - Goodlettsville Dermatology Research - Goodlettsville, Tennessee, United States
Local Institution - 0248 - Nashville, Tennessee, United States
Texas Dermatology and Laser Specialists - San Antonio, Texas, United States
Local Institution - 0280 - Southlake, Texas, United States
Local Institution - 0045 - Norfolk, Virginia, United States
Frontier Derm Partners - Mill Creek, Washington, United States
Local Institution - 0264 - Spokane, Washington, United States
Local Institution - 0254 - Bayamón, Puerto Rico
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin - Berlin, Germany
CONEXA Investigacion Clinica S.A. - Buenos Aires, Argentina
Hospital Italiano de Buenos Aires - Buenos Aires, Argentina
Hospital de Niños Dr. Ricardo Gutiérrez - Buenos Aires, Argentina
Derma Internacional - Buenos Aires, Argentina
Local Institution - 0008 - Caguas, Puerto Rico
Local Institution - 0259 - Chihuahua City, Mexico
Local Institution - 0286 - Cluj-Napoca, Romania
Debreceni Egyetem Klinikai Kozpont - Debrecen, Hungary
Universitaetsklinikum Carl Gustav Carus Dresden - Dresden, Germany
Universitaetsklinikum Erlangen - Erlangen, Germany
Policlinica Providența - Iași, Romania

Showing 60 of 132 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →