Phase 3 Study of Deucravacitinib to Treat Children and Teens Aged 5 to Under 18 With Juvenile Psoriatic Arthritis

What this Trial Is About

Researchers are evaluating the drug Deucravacitinib BMS-986165 in children and adolescents aged 5 to less than 18 years who have juvenile psoriatic arthritis. This Phase 3 trial aims to study the drugs levels in the body, how well it works, and its safety for this specific pediatric population. The trial is designed as a randomized withdrawal study comparing Deucravacitinib to placebo. Participants receive Deucravacitinib or placebo according to a specified dosing schedule. The study includes an initial treatment period followed by a withdrawal phase to monitor for disease flare. Key outcomes measured include time to first flare during the withdrawal period, drug concentration levels at steady state, achievement of low disease activity or inactive disease, and safety events such as adverse effects and uveitis occurrence. Throughout the study, participants will undergo clinical assessments including joint evaluations, disease activity scores, and psoriasis severity scales. Researchers will monitor for disease flares, remission status, and adverse events up to week 42. The trial includes pharmacokinetic analyses and evaluates participant-reported measures like taste and swallowability of the medication. Participation spans from screening through treatment and follow-up to capture comprehensive safety and efficacy data.

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis