A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study Followed by Active Treatment to Evaluate Apremilast in Children 2 to Under 18 With Oral Ulcers in Behçet's Disease

What this Trial Is About

Researchers are evaluating the effectiveness of apremilast compared to a placebo for treating oral ulcers in children aged 2 to under 18 years with Behçet's disease (BD). The study aims to measure how well apremilast works in reducing the number and pain of oral ulcers during a 12-week period. This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial sponsored by Amgen. Participants will be randomly assigned to receive either apremilast or a matching placebo orally for the first 12 weeks in a double-blind phase. After this period, all participants will continue receiving apremilast for an additional 40 weeks in an active treatment phase. The study monitors both the effects of the drug and safety throughout these phases. During the study, participants will have regular assessments of oral ulcer counts, pain levels, disease activity, and quality of life using tools like the Short Form Survey (SF-10). Safety will be closely monitored by tracking adverse events, suicide-related thoughts or behaviors, and physical growth measurements. Blood samples will be collected to measure apremilast levels. The total study participation lasts up to 56 weeks, including the treatment and follow-up periods.

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease