A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN)

Research summary

Behçet's disease (BD) is an inflammatory condition that causes damages of the blood vessels affecting many parts of the body. The disease is characterized by intermittent symptoms of varying severity across almost all organ systems and oral ulcers, considered the most common sign at the onset of BD and are observed in nearly every patient The treatment of BD is generally based on experience, and the drug of choice is based on specific clinical signs and symptoms in each patient. The primary objective of this study is to estimate the effectiveness of apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to < 18 years of age with oral ulcers associated with Behçet’s Disease through week 12. The total study duration for an individual subject is 62 weeks, comprising up to a 6 week screening phase, a 52 week treatment phase (12 week double-blind, placebo-controlled treatment phase and 40 week apremilast active treatment phase), and a 30 day posttreatment safety follow-up phase. The participants will be randomized to receive apremilast or placebo in the double-blind 12 week treatment phase. Then, the participants will all receive apremilast for a further 40 weeks in the active treatment phase. The participants will then complete a 30 day safety follow-up period after the last dose of apremilast in the active treatment phase. Apremilast (Otezla),works inside the cells to reduce inflammation. The current data for apremilast suggests a potential therapeutic benefit in the treatment of Behçet’s Disease. The study has an independent, external and unblinded Data Monitoring Committee (DMC), who will review data throughout the study to provide ongoing evaluations of subject safety.

Principal Investigator

Dr Akhila Kavirayani

Contact us

Email: childrensresearch@ouh.nhs.uk

IRAS number

291225