About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
Participants must have moderate to severe psoriasis defined by:.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Deucravacitinib
DrugSpecified dose on specified days
Placebo
Other interventionSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
Secondary outcomes
Number of participants achieving at least 90% improvement in PASI (PASI 90)
Change from baseline in PASI
Change from baseline in body surface area (BSA) involvement
Change from baseline in worst itch numeric rating scale (WI-NRS)
Sponsors and contacts
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