RecruitingPhase 3

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

AZ

CA

CO

FL

GA

ID

IN

KY

  • Kentucky Advanced Medical Research LLC · Murray, KY 42071Hollis Clark, Site 0262 · Study contactMore trials in Murray

LA

MA

MD

MI

MO

NC

NJ

NV

NY

OH

PA

TN

TX

VA

WA