Deucravacitinib for teens with moderate to severe plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adolescent participants with stable moderate to severe plaque psoriasis who meet entry thresholds (PASI ≥12, sPGA ≥3, BSA ≥10%) will be enrolled and assigned to receive deucravacitinib or a matching placebo. The study will collect clinical measures of skin disease, safety data, and blood drug levels over the treatment period. Key outcome measures include changes in PASI, sPGA, and BSA from baseline as well as adverse events and laboratory monitoring. The protocol includes contraception and pregnancy-related requirements for participants who are of childbearing potential.

Why it matters

Who can join: the full rules

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's running

• Center For Dermatology Clinical Research, Inc.
  Fremont, California, United States Recruiting
• Dermatology Research Associates
  Los Angeles, California, United States Recruiting
• Golden State Dermatology - Walnut Creek - Ygnacio Valley Road
  Walnut Creek, California, United States Recruiting
• Paradigm Clinical Research, LLC
  Wheat Ridge, Colorado, United States Recruiting
• Life Clinical Trials
  Margate, Florida, United States Recruiting
• Skin Research of South Florida
  Miami, Florida, United States Recruiting

+83 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study will test whether deucravacitinib or ustekinumab has better long-term safety for adults with moderate-to-severe plaque psoriasis who have cardiovascular risk factors.

  Recruiting at 323 sites Phase 3 Bristol-Myers Squibb · Birmingham, Alabama and 410 other locations · NCT07116967

• Comparing the effectiveness of deucravacitinib and apremilast for plaque psoriasis in adults in Japan

  This study is testing whether a new medication called deucravacitinib works better than apremilast for adults with plaque psoriasis in Japan.

  Recruiting at 2 sites Bristol-Myers Squibb · Minato-ku, Tokyo and 1 other locations · NCT06382987

• Evaluating Deucravacitinib for Pediatric Plaque Psoriasis

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• How safe and well ZP9830 works in people with plaque psoriasis over 8 weeks

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  Recruiting at 9 sites Novartis · Badalona, Barcelona and 8 other locations · NCT07683065

• Deucravacitinib for scarring hair loss (frontal fibrosing and central centrifugal alopecia)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.