A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis

Condition studied

Moderate to Severe Plaque Psoriasis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16., Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16., Safety (LTE): AEs and SAEs through study completion., Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.

Endpoint detail

Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16., Efficacy: Change from baseline in PASI at Week 16., Efficacy: Change from baseline in BSA involvement at Week 16., Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion., Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16., Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion., Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion., Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.