[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446242":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":63,"interventions":79,"overallOfficials":91,"centralContacts":95,"locations":105,"responsibleParty":351,"collaborators":53,"id":353,"slug":53,"hasResults":354,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":354,"sex":360,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":53,"studyType":366,"phases":367,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":108,"whyStopped":53,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline","HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period.","Week 24",[14,16,18,20,23,27,31,33,35,37,40,44,47,50],{"measure":15,"description":11,"timeFrame":12},"Double Blind Period: Number of new HO lesions from baseline",{"measure":17,"description":11,"timeFrame":12},"Double Blind Period: Total volume of new HO lesions from baseline",{"measure":19,"description":11,"timeFrame":12},"Double Blind Period: Change in the total volume of all HO lesions from baseline",{"measure":21,"description":22,"timeFrame":12},"Double Blind Period: Number of new flares from baseline","Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT).",{"measure":24,"description":25,"timeFrame":26},"Number of Participants with Treatment Emergent Adverse Events (TEAE)","Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.","Up to 316 weeks",{"measure":28,"description":29,"timeFrame":30},"Open-Label Extension: Occurrence of new HO lesions from Week 24","HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period.","Week 48",{"measure":32,"description":29,"timeFrame":30},"Open-Label Extension: Number of new HO lesions from Week 24",{"measure":34,"description":29,"timeFrame":30},"Open-Label Extension: Total volume of new HO lesions from Week 24",{"measure":36,"description":29,"timeFrame":30},"Open-Label Extension: Change in the total volume of all HO lesions from Week 24",{"measure":38,"description":39,"timeFrame":30},"Open-Label Extension: Number of new flares from Week 24","Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period.",{"measure":41,"description":42,"timeFrame":43},"Pharmacokinetics Parameter: Cmax of INCB000928","Maximum observed concentration.","Baseline, Weeks 12, 24, 48 and 76",{"measure":45,"description":46,"timeFrame":43},"Pharmacokinetics Parameter: Tmax of INCB000928","Time to maximum concentration.",{"measure":48,"description":49,"timeFrame":43},"Pharmacokinetics Parameter: Cmin of INCB000928","Minimum observed concentration.",{"measure":51,"description":52,"timeFrame":43},"Pharmacokinetics Parameter: AUCt of INCB000928","Area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":59,"maskingDescription":53,"whoMasked":60},"DOUBLE",[61,62],"PARTICIPANT","INVESTIGATOR",[64,71,75],{"label":65,"type":66,"description":67,"interventionNames":68},"Cohort 1","EXPERIMENTAL","Participants (≥ 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.",[69,70],"Drug: INCB000928","Drug: Placebo",{"label":72,"type":66,"description":73,"interventionNames":74},"Cohort 2","Participants (6 to \\\u003C 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.",[69,70],{"label":76,"type":66,"description":77,"interventionNames":78},"Cohort 3","Participants (2 to \\\u003C 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.",[69,70],[80,87],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"DRUG","INCB000928","INCBG000928 will be administered QD orally.",[65,72,76],[86],"zilurgisertib",{"type":81,"name":88,"description":89,"armGroupLabels":90,"otherNames":53},"Placebo","Placebo will be administered QD orally.",[65,72,76],[92],{"name":93,"affiliation":5,"role":94},"Amanda McBride, MD","STUDY_DIRECTOR",[96,101],{"name":97,"role":98,"phone":99,"phoneExt":53,"email":100},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":102,"role":98,"phone":103,"phoneExt":53,"email":104},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",[106,120,130,136,147,160,170,181,193,204,215,224,230,236,247,253,264,275,286,297,308,319,329,340],{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":53},"Mayo Clinic Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":115,"coordinates":116},"Point",[117,118],-92.4699,44.02163,{"lat":118,"lon":117},{"facility":121,"status":108,"city":122,"state":123,"zip":124,"country":112,"countryCode":113,"cosmosGeoPoint":125,"geoPoint":129,"contacts":53},"Children'S Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":115,"coordinates":126},[127,128],-75.16362,39.95238,{"lat":128,"lon":127},{"facility":131,"status":132,"city":122,"state":123,"zip":124,"country":112,"countryCode":113,"cosmosGeoPoint":133,"geoPoint":135,"contacts":53},"Penn Medicine - Perelman Center For Advanced Medicine","ACTIVE_NOT_RECRUITING",{"type":115,"coordinates":134},[127,128],{"lat":128,"lon":127},{"facility":137,"status":132,"city":138,"state":53,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":53},"Hospital Italiano de Buenos Aires","Buenos Aires","CO 1181","Argentina","AR",{"type":115,"coordinates":143},[144,145],-58.37723,-34.61315,{"lat":145,"lon":144},{"facility":148,"status":149,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":53},"Royal North Shore Hospital","COMPLETED","St Leonards","New South Wales","02065","Australia","AU",{"type":115,"coordinates":156},[157,158],151.19836,-33.82344,{"lat":158,"lon":157},{"facility":161,"status":132,"city":162,"state":163,"zip":164,"country":153,"countryCode":154,"cosmosGeoPoint":165,"geoPoint":169,"contacts":53},"Murdoch Children'S Research Institute","Parkville","Victoria","03052",{"type":115,"coordinates":166},[167,168],144.95,-37.78333,{"lat":168,"lon":167},{"facility":171,"status":132,"city":172,"state":53,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":53},"Albert Einstein Israelite Hospital","São Paulo","05652-900","Brazil","BR",{"type":115,"coordinates":177},[178,179],-46.63611,-23.5475,{"lat":179,"lon":178},{"facility":182,"status":132,"city":183,"state":184,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":53},"University Health Network Toronto General Hospital","Toronto","Ontario","M5G 2N2","Canada","CA",{"type":115,"coordinates":189},[190,191],-79.39864,43.70643,{"lat":191,"lon":190},{"facility":194,"status":132,"city":195,"state":53,"zip":196,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":53},"Centro de Estudios Reumatologicos","Santiago","7501126","Chile","CL",{"type":115,"coordinates":200},[201,202],-70.64827,-33.45694,{"lat":202,"lon":201},{"facility":205,"status":108,"city":206,"state":53,"zip":207,"country":208,"countryCode":209,"cosmosGeoPoint":210,"geoPoint":214,"contacts":53},"Beijing Childrens Hospital Capital Medical University","Beijing","100045","China","CN",{"type":115,"coordinates":211},[212,213],116.39723,39.9075,{"lat":213,"lon":212},{"facility":216,"status":108,"city":217,"state":53,"zip":218,"country":208,"countryCode":209,"cosmosGeoPoint":219,"geoPoint":223,"contacts":53},"Tongji Hospital of Tongji University","Shanghai","200065",{"type":115,"coordinates":220},[221,222],121.45806,31.22222,{"lat":222,"lon":221},{"facility":225,"status":108,"city":217,"state":53,"zip":226,"country":208,"countryCode":209,"cosmosGeoPoint":227,"geoPoint":229,"contacts":53},"Shanghai Childrens Medical Center","200127",{"type":115,"coordinates":228},[221,222],{"lat":222,"lon":221},{"facility":231,"status":108,"city":217,"state":53,"zip":232,"country":208,"countryCode":209,"cosmosGeoPoint":233,"geoPoint":235,"contacts":53},"Childrens Hospital of Fudan University","201102",{"type":115,"coordinates":234},[221,222],{"lat":222,"lon":221},{"facility":237,"status":108,"city":238,"state":53,"zip":239,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":53},"Ap-Hp Hopital Lariboisiere","Paris","75010","France","FR",{"type":115,"coordinates":243},[244,245],2.3488,48.85341,{"lat":245,"lon":244},{"facility":248,"status":108,"city":238,"state":53,"zip":249,"country":240,"countryCode":241,"cosmosGeoPoint":250,"geoPoint":252,"contacts":53},"Hopital Necker-Enfants Malades","75015",{"type":115,"coordinates":251},[244,245],{"lat":245,"lon":244},{"facility":254,"status":108,"city":255,"state":53,"zip":256,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":53},"Uniklinik Koln","Cologne","50931","Germany","DE",{"type":115,"coordinates":260},[261,262],6.95,50.93333,{"lat":262,"lon":261},{"facility":265,"status":132,"city":266,"state":53,"zip":267,"country":268,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":53},"Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore","Rome","00168","Italy","IT",{"type":115,"coordinates":271},[272,273],12.51133,41.89193,{"lat":273,"lon":272},{"facility":276,"status":132,"city":277,"state":53,"zip":278,"country":279,"countryCode":280,"cosmosGeoPoint":281,"geoPoint":285,"contacts":53},"Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra","Tlalpan","14389","Mexico","MX",{"type":115,"coordinates":282},[283,284],-99.16206,19.29513,{"lat":284,"lon":283},{"facility":287,"status":108,"city":288,"state":53,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":53},"Amsterdam Umc - Vu Medisch Centrum (Vumc)","Amsterdam","1081 HV","Netherlands","NL",{"type":115,"coordinates":293},[294,295],4.88969,52.37403,{"lat":295,"lon":294},{"facility":298,"status":132,"city":299,"state":53,"zip":300,"country":301,"countryCode":302,"cosmosGeoPoint":303,"geoPoint":307,"contacts":53},"Starship Childrens Hospital","Auckland","01023","New Zealand","NZ",{"type":115,"coordinates":304},[305,306],174.76349,-36.84853,{"lat":306,"lon":305},{"facility":309,"status":132,"city":310,"state":53,"zip":311,"country":312,"countryCode":313,"cosmosGeoPoint":314,"geoPoint":318,"contacts":53},"Groote Schuur Hospital Radiation Oncology","Cape Town","07925","South Africa","ZA",{"type":115,"coordinates":315},[316,317],18.42322,-33.92584,{"lat":317,"lon":316},{"facility":320,"status":132,"city":321,"state":53,"zip":322,"country":323,"countryCode":53,"cosmosGeoPoint":324,"geoPoint":328,"contacts":53},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":115,"coordinates":325},[326,327],126.9784,37.566,{"lat":327,"lon":326},{"facility":330,"status":108,"city":331,"state":53,"zip":332,"country":333,"countryCode":334,"cosmosGeoPoint":335,"geoPoint":339,"contacts":53},"Hospital Universitario Ramon Y Cajal","Madrid","28034","Spain","ES",{"type":115,"coordinates":336},[337,338],-3.70256,40.4165,{"lat":338,"lon":337},{"facility":341,"status":132,"city":342,"state":53,"zip":343,"country":344,"countryCode":345,"cosmosGeoPoint":346,"geoPoint":350,"contacts":53},"Royal National Orthopaedic Hospital","Stanmore","HA7 4LP","United Kingdom","UK",{"type":115,"coordinates":347},[348,349],-0.31667,51.61667,{"lat":349,"lon":348},{"type":352,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100446242",false,"NCT05090891","To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","Progress","Inclusion Criteria:\n\n* Female and male participants:\n\n  * Cohort 1: ≥ 12 years of age.\n  * Cohort 2: 6 to \\\u003C 12 years of age.\n  * Cohort 3: 2 to \\\u003C 12 years of age (after eDMC review of safety data from Cohort 2).\n* Clinical diagnosis of FOP.\n* Willingness to avoid pregnancy or fathering children based on the criteria below.\n* Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding.\n* CAJIS score ≥ 24.\n* FOP disease severity that in the investigator's opinion precludes participation.\n* Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.\n* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.\n* HIV, HBV, or HCV infection. Note:\n* Further exclusion criteria apply.","ALL","2 Years","99 Years",{"count":364,"type":365},98,"ESTIMATED","INTERVENTIONAL",[368],"PHASE2","This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).",[371],"Fibrodysplasia Ossificans Progressiva (FOP)",[373,374],"fibrodysplasia ossificans progressiva (FOP)","heterotopic ossification","2026-05-19",{"date":377,"type":378},"2026-05-22","ACTUAL",{"date":380,"type":378},"2022-05-05",{"date":382,"type":365},"2033-01-20",{"name":5,"class":6},24]