A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
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
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests deucravacitinib (BMS-986165) in teens with moderate to severe plaque psoriasis, a skin condition that causes thick, scaly patches. It looks at how well the drug works, its safety, and its levels in the body.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have plaque psoriasis that has been stable for at least 6 months before screening.
- At screening and Day 1, have a psoriasis area and severity score (PASI) of at least 12 and a doctor's rating (sPGA) of at least 3.
- Have psoriasis covering at least 10% of the body at screening and Day 1.
- If assigned female at birth, must not be pregnant or breastfeeding.
- If able to become pregnant, use birth control with a failure rate below 1% per year during treatment and for at least 3 days after stopping. Do not donate eggs during that time.
Who can't join
- Weigh less than 30 kg (about 66 pounds) at screening or Day 1.
- Have a different type of psoriasis or another skin condition that could affect study results at screening or Day 1.
- Had a serious infection needing a hospital stay and infection medicine through a vein within 60 days before Day 1; had an untreated bacterial infection during that time; or have an ongoing, long-term bacterial infection.
- Meet study rules that exclude people with herpes simplex, shingles, active tuberculosis (TB), hepatitis B or C, or HIV.
- Received a live vaccine or BCG vaccine within 60 days before Day 1, or plan to receive a live vaccine during the study or within 60 days after treatment ends.
- Have used deucravacitinib before, take a medicine the study does not allow, or have a lab result that rules out joining.
- Have a major illness or unstable health condition that the study doctor believes would greatly increase the risks of joining.
- Have cancer, had cancer within the past 5 years, or had a disease causing too many immune cells within the past 5 years. Other study rules also apply.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (47)
AL
- Local Institution - 0261 · Birmingham, AL 35203Site 0261 · Study contactMore trials in Birmingham
- Local Institution - 0041 · Birmingham, AL 35243Site 0041 · Study contactMore trials in Birmingham
AZ
- Local Institution - 0053 · Phoenix, AZ 85006More trials in Phoenix
CA
- Local Institution - 0025 · Fountain Valley, CA 92708Site 0025 · Study contactMore trials in Fountain Valley
- Center For Dermatology Clinical Research, Inc. · Fremont, CA 94538Sunil Dhawan, Site 0090 · Study contact · 510-599-4750More trials in Fremont
- Dermatology Research Associates · Los Angeles, CA 90045Howard Sofen, Site 0006 · Study contact · 310-337-7171More trials in Los Angeles
- Northridge Clinical Trials · Northridge, CA 91325Navid Ezra, Site 0214 · Study contact · 818-350-7483More trials in Northridge
- Local Institution - 0077 · Sacramento, CA 95814Site 0077 · Study contactMore trials in Sacramento
- Golden State Dermatology - Walnut Creek - Ygnacio Valley Road · Walnut Creek, CA 94598Michael Wang, Site 0243 · Study contact · 507-261-3758More trials in Walnut Creek
CO
- Paradigm Clinical Research, LLC · Wheat Ridge, CO 80033Kimberly Neyman, Site 0231 · Study contact · 303-463-1947More trials in Wheat Ridge
FL
- Local Institution - 0021 · Clearwater, FL 33756Site 0021 · Study contactMore trials in Clearwater
- Life Clinical Trials · Margate, FL 33063Eli Saleeby, Site 0185 · Study contact · 954-849-0902More trials in Margate
- Skin Research of South Florida · Miami, FL 33173Giovanna Ciocca, Site 0043 · Study contact · 305-707-9852More trials in Miami
- Wellness Clinical Research · Miami Lakes, FL 33016David Rodriguez, Site 0014 · Study contact · 786-483-7856More trials in Miami Lakes
- MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research · Tampa, FL 33607Stephen Lockwood, Site 0070 · Study contact · 813-948-7550More trials in Tampa
- USF Health · Tampa, FL 33612Sharon Albers, Site 0171 · Study contact · 813-974-4381More trials in Tampa
GA
- Dermatology Affiliates Research Institute · Atlanta, GA 30305Adebayo Akinsola, Site 0244 · Study contact · 770-733-1077More trials in Atlanta
- Advanced Medical Research, PC. · Sandy Springs, GA 30328Jamie Weisman, Site 0072 · Study contact · 404-939-9220More trials in Sandy Springs
ID
- Local Institution - 0271 · Ammon, ID 83406Site 0271 · Study contactMore trials in Ammon
IN
- Dawes Fretzin Clinical Research Group, LLC · Indianapolis, IN 46250Scott Fretzin, Site 0003 · Study contact · 317-516-5030More trials in Indianapolis
KY
- Kentucky Advanced Medical Research LLC · Murray, KY 42071Hollis Clark, Site 0262 · Study contactMore trials in Murray
LA
- Local Institution - 0202 · Metairie, LA 70001Site 0202 · Study contactMore trials in Metairie
MA
- Kuchnir Dermatology & Dermatologic Surgery · Milford, MA 01757Shiu-Chung Au, Site 0220 · Study contact · 000-000-0000More trials in Milford
MD
- Dermatology and Skin Cancer Specialists, LLC · Rockville, MD 20850Benjamin Lockshin, Site 0061 · Study contact · 301-355-3183More trials in Rockville
MI
- C.S. Mott Clinical Research Center (CRC) · Detroit, MI 48201Geoffrey Potts, Site 0095 · Study contact · 248-581-5243More trials in Detroit
- Henry Ford Medical Center · Detroit, MI 48202-3141Linda Stein Gold, Site 0065 · Study contact · 248-884-5356More trials in Detroit
MO
- Local Institution - 0233 · Columbia, MO 65201Site 0233 · Study contactMore trials in Columbia
- Local Institution - 0278 · Columbia, MO 65212Site 0278 · Study contactMore trials in Columbia
- Dermatology and Skin Cancer Center · Lee's Summit, MO 64064Mark Fleischman, Site 0266 · Study contact · 913-451-7546More trials in Lee's Summit
NC
- Local Institution - 0234 · Hickory, NC 28602More trials in Hickory
NJ
- Local Institution - 0283 · Clifton, NJ 07013Site 0283 · Study contactMore trials in Clifton
- Local Institution - 0281 · Robbinsville, NJ 08691Site 0281 · Study contactMore trials in Robbinsville
NV
- JDR Dermatology Research · Las Vegas, NV 89148James Del Rosso, Site 0052 · Study contact · 702-596-6137More trials in Las Vegas
NY
- Local Institution - 0273 · Brooklyn, NY 11203Site 0273 · Study contactMore trials in Brooklyn
- Local Institution - 0205 · New York, NY 10075Site 0205 · Study contactMore trials in New York
- Local Institution - 0166 · The Bronx, NY 10467Site 0166 · Study contactMore trials in The Bronx
OH
- Apex Clinical Research Center - Canton · Canton, OH 44716Jorge Garcia-Zuazaga, Site 0251 · Study contact · 14404404430440More trials in Canton
- Apex Clinical Research Center · Lorain, OH 44053Garcia-Zuazaga Jorge, Site 0275 · Study contactMore trials in Lorain
- Apex Clinical Research Center · Mayfield Heights, OH 44124Brian Moore, Site 0055 · Study contact · 440-940-2739More trials in Mayfield Heights
PA
- Paddington Testing Company · Philadelphia, PA 19103Jennifer Parish, Site 0073 · Study contact · 215-563-7330More trials in Philadelphia
TN
- ObjectiveHealth - Goodlettsville Dermatology Research · Goodlettsville, TN 37072Keith Loven, Site 0235 · Study contact · 615-241-2820More trials in Goodlettsville
- Local Institution - 0248 · Nashville, TN 37205More trials in Nashville
TX
- Texas Dermatology and Laser Specialists · San Antonio, TX 78218John Browning, Site 0033 · Study contact · 210-704-4037More trials in San Antonio
- Local Institution - 0280 · Southlake, TX 76092Site 0280 · Study contactMore trials in Southlake
VA
- Local Institution - 0045 · Norfolk, VA 23502Site 0045 · Study contactMore trials in Norfolk
WA
- Frontier Derm Partners · Mill Creek, WA 98012Eingun Song, Site 0071 · Study contact · 425-275-4404More trials in Mill Creek
- Local Institution - 0264 · Spokane, WA 99204Site 0264 · Study contactMore trials in Spokane