[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629384":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":123,"collaborators":125,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":31,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":31,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":37,"whyStopped":31,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Inozyme Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"INZ-701","EXPERIMENTAL","Participants receive INZ-701 (rhENPP1-Fc) administered by subcutaneous injection once weekly at the protocol-specified dose. The visit final volume to administer (mL) is determined using protocol-defined parameters.",[13],"Drug: INZ-701",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.",[9],[20],"(rhENPP1-Fc).",[22],{"name":23,"affiliation":24,"role":25},"Medical Director, MD","BioMarin Pharmaceutical","STUDY_DIRECTOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Trial Specialist","CONTACT","+1 800-983-4587",null,"medinfo@bmrn.com",{"name":23,"role":29,"phone":30,"phoneExt":31,"email":32},[35,48,59,69,80,91,103,112],{"facility":36,"status":37,"city":38,"state":31,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":31},"Hospital Universitario Pedro Ernesto\u002FRio de Janeiro","RECRUITING","Rio de Janeiro","20551-030","Brazil","BR",{"type":43,"coordinates":44},"Point",[45,46],-43.18223,-22.90642,{"lat":46,"lon":45},{"facility":49,"status":37,"city":50,"state":31,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":31},"Hopital Necker - Enfants Malades","Paris","75015","France","FR",{"type":43,"coordinates":55},[56,57],2.3488,48.85341,{"lat":57,"lon":56},{"facility":60,"status":37,"city":61,"state":31,"zip":31,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":31},"Gyermekgyogyaszat, DE","Debrecen","Hungary","HU",{"type":43,"coordinates":65},[66,67],21.62444,47.53167,{"lat":67,"lon":66},{"facility":70,"status":37,"city":71,"state":31,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":31},"Azienda Ospedaliera Universitaria Meyer","Florence","50139","Italy","IT",{"type":43,"coordinates":76},[77,78],11.24626,43.77925,{"lat":78,"lon":77},{"facility":81,"status":37,"city":82,"state":31,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":31},"King Faisal Specialist Hospital and Research Center","Riyadh","12713","Saudi Arabia","SA",{"type":43,"coordinates":87},[88,89],46.72185,24.68773,{"lat":89,"lon":88},{"facility":92,"status":37,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":31},"Hospital Sant Joan de Deu Edificio Consultas Externas. Unitat de Recerca","Barcelona","Esplugues de Llobregat","08950","Spain","ES",{"type":43,"coordinates":99},[100,101],2.15899,41.38879,{"lat":101,"lon":100},{"facility":104,"status":37,"city":105,"state":31,"zip":31,"country":106,"countryCode":31,"cosmosGeoPoint":107,"geoPoint":111,"contacts":31},"Umraniye Traiing and Research Hospital","Istanbul","Turkey (Türkiye)",{"type":43,"coordinates":108},[109,110],28.94966,41.01384,{"lat":110,"lon":109},{"facility":113,"status":37,"city":114,"state":31,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":31},"Royal Manchester Children's Hospital","Manchester","M13 9WL","United Kingdom","UK",{"type":43,"coordinates":119},[120,121],-2.23743,53.48095,{"lat":121,"lon":120},{"type":124,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[126],{"name":24,"class":6},"100629384","phase-3-energy-2-evaluation-of-the-efficacy-and-safety-of-inz-701-in-infants-with-enpp1-deficiency-100629384",false,"NCT07473973","ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency","The ENERGY 2 Study: An Open-Label Phase 3 Study to Evaluate the Efficacy and Safety of INZ-701 in Infants With Ectonucleotide Pyrophosphatase\u002FPhosphodiesterase 1 (ENPP1) Deficiency","Participants must meet all of the following:\n\nInclusion Criteria:\n\n1. Infant aged ≤ 1 year at the time of enrollment.\n2. Confirmed diagnosis of ENPP1 deficiency, based on genetic testing.\n3. Clinical features consistent with generalized arterial calcification of infancy (GACI) (e.g., vascular calcification or cardiac involvement).\n4. Medically stable to participate in a 52-week treatment study.\n5. Written informed consent provided by a parent or legal guardian.\n\nExclusion Criteria\n\nParticipants will not be eligible if any of the following apply:\n\n1. Receiving end-of-life or hospice care.\n2. Prior treatment with INZ-701, unless received through an approved expanded access program.\n3. Concurrent participation in another interventional clinical trial.\n4. Planned major surgery during the study period that would interfere with study participation.","ALL","0 Years","1 Year",{"count":138,"type":139},12,"ESTIMATED","INTERVENTIONAL",[142],"PHASE3","The primary purpose of ENERGY 2 (Study INZ701-105) is to assess the efficacy and safety of INZ-701 in infants with ENPP1 Deficiency.",[145,146,147],"Ectonucleotide Pyrophosphatase\u002Fphosphodiesterase1 Deficiency","Autosomal Recessive Hypophosphatemic Rickets","Generalized Arterial Calcification of Infancy 1",[149,150,151,152],"Generalized Arterial Calcification of Infancy","GACI","Autosomal Recessive Hypophosphatemic Rickets Type 2","ARHR2","2026-03-16",{"date":155,"type":156},"2026-03-18","ACTUAL",{"date":158,"type":156},"2025-03-26",{"date":160,"type":139},"2028-11-07",{"name":5,"class":6},8]