Phase 3 Study of Apremilast for Treating Active Juvenile Psoriatic Arthritis in Children Ages 5 to Under 18

What this Trial Is About

Researchers are evaluating the effectiveness of apremilast compared with placebo for treating children aged 5 to less than 18 years with active juvenile psoriatic arthritis JPsA. This phase 3, double-blind, randomized, placebo-controlled study aims to assess how well apremilast works in improving symptoms and disease activity in pediatric participants with JPsA. Participants will be randomly assigned to receive either apremilast or a matching placebo orally during a 16-week double-blind treatment phase. After this period, all participants will continue with apremilast treatment for an additional 36 weeks in an open-label phase. The study will monitor the safety, efficacy, and pharmacokinetics of apremilast throughout these treatment periods. Participants will undergo regular assessments including evaluations of joint activity, pain levels, physician and participant disease activity ratings, and laboratory markers of inflammation. Researchers will measure responses using the American College of Rheumatology Pediatric ACR Pedi criteria and other disease activity scores. Safety monitoring includes tracking treatment-emergent adverse events and suicidal ideation. The study lasts a total of 52 weeks, with evaluations of growth and development included during the later weeks.

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis