Phase 3 Study of Apremilast to Treat Oral Ulcers in Children Aged 2 to Under 18 With Behets Disease

What this Trial Is About

This trial evaluates the effects of apremilast compared to placebo in children aged 2 to under 18 years who have active oral ulcers caused by Behets disease. The goal is to understand how well apremilast works in treating these oral ulcers during a 12-week period. This study is a Phase 3, multicenter, randomized, placebo-controlled trial designed to provide important information about treatment options for pediatric patients with this condition. Participants are randomly assigned to receive either apremilast or a matching placebo orally for the first 12 weeks in a double-blind phase. After this, all participants receive apremilast for an additional 40 weeks in an active treatment phase. This design allows researchers to compare the initial effect of apremilast to placebo and then monitor longer-term treatment effects in all participants. Throughout the study, participants will be assessed for the number of oral ulcers over 12 weeks, pain levels, complete response rates, and changes in disease activity. Safety is closely monitored up to 56 weeks, including adverse events and growth measurements such as height, weight, and body mass index. Researchers also track plasma levels of apremilast and acceptability of the treatment. The total participation lasts up to 56 weeks to capture both short- and long-term outcomes.

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