RecruitingPlaque Psoriasis

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

Eligible age

12–17 yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

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

Sponsor: Bristol-Myers Squibb

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.