Connor Downs

Researchers are evaluating the drug levels, effectiveness, and safety of Deucravacitinib in children aged 4 to under 18 years who have moderate to severe plaque psoriasis. The study includes two age groups: Cohort 1 for ages 12 to under 18, and Cohort 2 for ages 4 to under 12. Each cohort has two parts, with Part A focusing on determining the appropriate dose levels of Deucravacitinib, and Part B assessing how well two selected dose levels work and their safety. A long-term extension phase lasting up to five years will monitor the ongoing safety and tolerability of the medication in young participants who completed the initial study parts. Participants receive Deucravacitinib or a matching placebo at specified doses on set days. Part A evaluates drug levels to select doses for Part B, which then measures efficacy and safety of the chosen doses in pediatric patients with moderate to severe plaque psoriasis. Following Parts A or B, participants may enter the long-term extension period to continue safety and tolerability assessments over several years. Throughout the study, researchers will measure drug concentrations in the blood at Week 2 and assess clinical improvements at Week 16 using the Psoriasis Area and Severity Index and Physician's Global Assessment scores. Safety monitoring includes tracking adverse events, serious adverse events, and growth measures such as weight, height, and sexual maturation stages for up to 316 weeks. This comprehensive evaluation helps understand how the drug works and its impact on children's health over both short and long periods.