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Then the participants will continue to receive apremilast in the active 40 weeks treatment phase.",[13],"Drug: Apremilast",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo to Apremilast","PLACEBO_COMPARATOR","Participants will receive the matching placebo orally in the double-blind 12 week treatment phase. 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Fe","Valencia","46026",{"type":50,"coordinates":178},[179,180],-0.37966,39.47391,{"lat":180,"lon":179},{"facility":183,"status":45,"city":184,"state":31,"zip":185,"country":148,"cosmosGeoPoint":186,"geoPoint":190,"contacts":31},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":50,"coordinates":187},[188,189],-3.70256,40.4165,{"lat":189,"lon":188},{"facility":192,"status":57,"city":184,"state":31,"zip":193,"country":148,"cosmosGeoPoint":194,"geoPoint":196,"contacts":31},"Hospital Universitario La Paz","28046",{"type":50,"coordinates":195},[188,189],{"lat":189,"lon":188},{"facility":198,"status":57,"city":199,"state":31,"zip":200,"country":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":31},"Centre Hospitalier Universitaire 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Fakultesi","34098",{"type":50,"coordinates":230},[223,224],{"lat":224,"lon":223},{"facility":233,"status":45,"city":219,"state":31,"zip":234,"country":211,"cosmosGeoPoint":235,"geoPoint":237,"contacts":31},"Umraniye Egitim ve Arastirma Hastanesi","34764",{"type":50,"coordinates":236},[223,224],{"lat":224,"lon":223},{"facility":239,"status":57,"city":240,"state":31,"zip":241,"country":211,"cosmosGeoPoint":242,"geoPoint":246,"contacts":31},"Dokuz Eylul Universitesi Tip Fakultesi Hastanesi","Izmir","35330",{"type":50,"coordinates":243},[244,245],27.13838,38.41273,{"lat":245,"lon":244},{"facility":248,"status":45,"city":249,"state":31,"zip":250,"country":211,"cosmosGeoPoint":251,"geoPoint":255,"contacts":31},"Erciyes Universitesi Tip Fakultesi Hastanesi","Kayseri","38030",{"type":50,"coordinates":252},[253,254],35.48528,38.73222,{"lat":254,"lon":253},{"facility":257,"status":57,"city":258,"state":31,"zip":259,"country":260,"cosmosGeoPoint":261,"geoPoint":265,"contacts":31},"Birmingham Childrens Hospital","Birmingham","B4 6NH","United Kingdom",{"type":50,"coordinates":262},[263,264],-1.89983,52.48142,{"lat":264,"lon":263},{"facility":267,"status":45,"city":268,"state":31,"zip":269,"country":260,"cosmosGeoPoint":270,"geoPoint":274,"contacts":31},"Alder Hey Childrens Hospital","Liverpool","L12 2AP",{"type":50,"coordinates":271},[272,273],-2.97794,53.41058,{"lat":273,"lon":272},{"facility":276,"status":45,"city":277,"state":31,"zip":278,"country":260,"cosmosGeoPoint":279,"geoPoint":283,"contacts":31},"John Radcliffe Hospital","Oxford","OX3 7LD",{"type":50,"coordinates":280},[281,282],-1.25596,51.75222,{"lat":282,"lon":281},{"type":285,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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":297,"type":298},60,"ESTIMATED","INTERVENTIONAL",[301],"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.",[304],"Behçet Disease",[306,307,9],"Behçet's Disease","Oral ulcers","2025-11-26",{"date":310,"type":311},"2025-12-01","ACTUAL",{"date":313,"type":311},"2021-09-09",{"date":315,"type":298},"2030-12-17",{"name":5,"class":6},27]