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Kingdom","UK",{"type":51,"coordinates":269},[270,271],-1.89983,52.48142,{"lat":271,"lon":270},{"facility":274,"status":45,"city":275,"state":31,"zip":276,"country":266,"countryCode":267,"cosmosGeoPoint":277,"geoPoint":281,"contacts":31},"Alder Hey Childrens Hospital","Liverpool","L12 2AP",{"type":51,"coordinates":278},[279,280],-2.97794,53.41058,{"lat":280,"lon":279},{"facility":283,"status":45,"city":284,"state":31,"zip":285,"country":266,"countryCode":267,"cosmosGeoPoint":286,"geoPoint":290,"contacts":31},"John Radcliffe Hospital","Oxford","OX3 7LD",{"type":51,"coordinates":287},[288,289],-1.25596,51.75222,{"lat":289,"lon":288},{"type":292,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100403037","phase-3-apremilast-pediatric-study-in-children-with-active-oral-ulcers-associated-with-behets-disease-100403037",false,"NCT04528082","Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease","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)","BEAN","Key Inclusion Criteria\n\n* Male or Female participants 2 to \\\u003C 18 years of age at randomization.\n* Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.\n* Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit.\n* Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1.\n* Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.\n\nKey Exclusion Criteria\n\n* Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:\n\n  * Previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment\n  * Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed\n  * Participants with BD-related arthritis and BD-skin manifestations are also allowed.\n* Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).","ALL","2 Years","17 Years",{"count":305,"type":306},60,"ESTIMATED","INTERVENTIONAL",[309],"PHASE3","The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to \\\u003C 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.",[312],"Behçet Disease",[314,315,9],"Behçet's Disease","Oral ulcers","2025-11-26",{"date":318,"type":319},"2025-12-01","ACTUAL",{"date":321,"type":319},"2021-09-09",{"date":323,"type":306},"2030-12-17",{"name":5,"class":6},27]