[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498191":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":34,"responsibleParty":104,"collaborators":32,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":32,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":32,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Apremilast","EXPERIMENTAL","Participants with a weight between ≥ 12 kg to \\\u003C 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to \\\u003C 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.",[13],"Drug: Apremilast",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Oral tablets or liquid suspension",[9],[20,21,22],"AMG 407","Otezla","CC-10004",[24],{"name":25,"affiliation":5,"role":26},"MD","STUDY_DIRECTOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Amgen Call Center","CONTACT","866-572-6436",null,"medinfo@amgen.com",[35,48,59,70,79,89,98],{"facility":36,"status":37,"city":38,"state":32,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":32},"General Hospital of Thessaloniki Ippokrateio","RECRUITING","Thessaloniki","54642","Greece","GR",{"type":43,"coordinates":44},"Point",[45,46],22.93493,40.64072,{"lat":46,"lon":45},{"facility":49,"status":37,"city":50,"state":32,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":32},"Meir Medical Center","Kfar Saba","4428164","Israel","IL",{"type":43,"coordinates":55},[56,57],34.90694,32.175,{"lat":57,"lon":56},{"facility":60,"status":37,"city":61,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":32},"Hospital Universitari i Politecnic La Fe","Valencia","46026","Spain","ES",{"type":43,"coordinates":66},[67,68],-0.37966,39.47391,{"lat":68,"lon":67},{"facility":71,"status":37,"city":72,"state":32,"zip":73,"country":63,"countryCode":64,"cosmosGeoPoint":74,"geoPoint":78,"contacts":32},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":43,"coordinates":75},[76,77],-3.70256,40.4165,{"lat":77,"lon":76},{"facility":80,"status":37,"city":81,"state":32,"zip":82,"country":83,"countryCode":32,"cosmosGeoPoint":84,"geoPoint":88,"contacts":32},"Hacettepe Universitesi Tip Fakultesi Hastanesi","Ankara","06100","Turkey (Türkiye)",{"type":43,"coordinates":85},[86,87],32.85427,39.91987,{"lat":87,"lon":86},{"facility":90,"status":37,"city":91,"state":32,"zip":92,"country":83,"countryCode":32,"cosmosGeoPoint":93,"geoPoint":97,"contacts":32},"Istanbul Universitesi Cerrahpasa Tip Fakultesi","Istanbul","34098",{"type":43,"coordinates":94},[95,96],28.94966,41.01384,{"lat":96,"lon":95},{"facility":99,"status":37,"city":91,"state":32,"zip":100,"country":83,"countryCode":32,"cosmosGeoPoint":101,"geoPoint":103,"contacts":32},"Umraniye Egitim ve Arastirma Hastanesi","34764",{"type":43,"coordinates":102},[95,96],{"lat":96,"lon":95},{"type":105,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100498191","phase-3-a-study-of-apremilast-in-children-with-oral-ulcers-associated-with-behets-disease-or-juvenile-psoriatic-arthritis-100498191",false,"NCT05767047","A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis","A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis","Inclusion Criteria:\n\n* Informed consent \u002F assent obtained\n* Must have completed Week 52 on treatment on core study and must be \\\u003C 18 years of age at the time the informed consent document is signed\n* Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment\n* Willing to adhere to study visit schedule and protocol requirements\n* Must have acceptable benefit\u002Frisk for continued treatment with apremilast\n\nExclusion Criteria:\n\n* Answer \"yes\" to any question on C-SSRS at Week 52 visit of core study\n* Scheduled surgery or other interventions that would interrupt study participation\n* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose\n* Female participants planning to become pregnant while on study through 30 days after last dose\n* Female participants of childbearing potential with positive pregnancy test at Week 0\n* Known sensitivity to any products to be administered during dosing","ALL","5 Years","18 Years",{"count":117,"type":118},48,"ESTIMATED","INTERVENTIONAL",[121],"PHASE3","The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.",[124,125],"Behçet's Disease","Juvenile Psoriatic Arthritis",[127,124,125,9,20,21],"Oral Ulcers","2025-11-26",{"date":130,"type":131},"2025-12-01","ACTUAL",{"date":133,"type":131},"2023-03-23",{"date":135,"type":118},"2036-03-17",{"name":5,"class":6},7]