Connor Downs

Researchers are studying the drug Deucravacitinib in children and adolescents aged 4 to under 18 years who have moderate to severe plaque psoriasis. The study aims to evaluate the drug levels, efficacy, and safety of Deucravacitinib in this population. It includes two age groups Cohort 1 for ages 12 to under 18 years and Cohort 2 for ages 4 to under 12 years. The study is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Bristol-Myers Squibb. The study consists of two parts for each cohort. Part A will assess the drug levels of Deucravacitinib to select two dose levels for Part B. Part B will then evaluate the efficacy and safety of these two dose levels. There is also a 5-year long-term extension period to observe the long-term safety and tolerability of Deucravacitinib in participants who completed Parts A or B. Participants will undergo assessments including measuring drug concentrations at steady state, improvement in psoriasis severity using PASI and sPGA scores, and monitoring of adverse events over time. Growth and sexual maturation will be tracked through body weight, height, and Tanner staging. Safety labs and other clinical tests will also be conducted up to 52 weeks, with longer-term monitoring for some outcomes extending up to 316 weeks.