[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609390":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":43,"interventions":60,"overallOfficials":31,"centralContacts":71,"locations":77,"responsibleParty":101,"collaborators":31,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":31,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":31,"enrollmentInfo":112,"targetDuration":31,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":80,"whyStopped":31,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Apellis Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR)","Change from Baseline in Log-Transformed uPCR will be based on triplicate first morning urine (FMU)","Baseline to Week 12",{"measure":14,"description":15,"timeFrame":16},"Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR)","Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)","Baseline to Week 52",[18,21,24,28],{"measure":19,"description":20,"timeFrame":12},"Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine albumin to creatinine ratio (uACR)","Change From Baseline in Log-Transformed uACR will be based on first morning urine (FMU)",{"measure":22,"description":15,"timeFrame":23},"Phase 3: Change from Baseline in log-transformed urine protein to creatinine ratio (uPCR)","Baseline to Week 104",{"measure":25,"description":26,"timeFrame":27},"Phase 3: Proportion of participants achieving Complete Remission","Complete Remission is defined as participants who have achieved uPCR \\\u003C0.3 g\u002Fg","Week 104",{"measure":29,"description":30,"timeFrame":23},"Phase 3: Slope of estimated Glomerular Filtration Rate (eGFR)","The annualized eGFR slope",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":38},"QUADRUPLE",[39,40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50,54],{"label":45,"type":46,"description":47,"interventionNames":48},"Phase 2 - APL2","EXPERIMENTAL","Sub-cutaneous infusions of APL2 (1080 mg \u002F 20mL) twice weekly",[49],"Drug: APL2",{"label":51,"type":46,"description":52,"interventionNames":53},"Phase 3 - APL2","Adults: Sub-cutaneous infusions of APL2 (1080 mg \u002F 20mL) twice weekly\n\nAdolescents:\n\n≥50 Kg: Sub-cutaneous infusions of APL2 (1080 mg \u002F 20mL) twice weekly 35 to \\\u003C50kg: First sub-cutaneous infusion of 648mg (12 mL) followed by 810mg (15 mL) every infusion thereafter (i.e. twice weekly) 30 to \\\u003C35kg: First \\& Second sub-cutaneous infusion of 540mg (10mL) followed by 648mg (12 mL) every infusion thereafter (twice weekly)",[49],{"label":55,"type":56,"description":57,"interventionNames":58},"Phase 3 - Placebo","PLACEBO_COMPARATOR","Subcutaneous infusions of a sterile solution, twice-weekly, and equivalent in volume to the active arm based on participant's age and weight",[59],"Other: Placebo",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":31},"DRUG","APL2","Complement (C3) Inhibitor",[45,51],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":31},"OTHER","Placebo","Sterile solution of equal volume to active arm",[55],[72],{"name":73,"role":74,"phone":75,"phoneExt":31,"email":76},"Apellis Clinical Trial Information Line","CONTACT","833-284-6361","clinicaltrials@apellis.com",[78,92],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":31},"Investigator Site 1","RECRUITING","Chicago","Illinois","60643","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-87.65005,41.85003,{"lat":90,"lon":89},{"facility":93,"status":80,"city":94,"state":94,"zip":95,"country":84,"countryCode":85,"cosmosGeoPoint":96,"geoPoint":100,"contacts":31},"Investigator Site 2","New York","10032",{"type":87,"coordinates":97},[98,99],-74.00597,40.71427,{"lat":99,"lon":98},{"type":102,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100609390","phase-2-a-sequential-phase-23-study-of-apl2-in-patients-with-focal-segmental-glomerulosclerosis-100609390",false,"NCT07213960","A Sequential Phase 2\u002F3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis","A Sequential Phase 2\u002F3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of APL2 in Adults and Adolescents With Focal Segmental Glomerulosclerosis","Inclusion Criteria:\n\n* Age\n\n  * Phase 2: adults aged ≥18 years\n  * Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form\n* Weight ≥30 kg and ≤100 kg at screening\n* FSGS diagnosis\n\n  * Phase 2: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy\n  * Phase 3: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy or by recognized podocyte genetic mutation\n* At least 1.5 g\u002Fday of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g\u002Fg in at least 2 FMU samples collected during screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2\n* Stable regimen for FSGS treatment for at least 12 weeks prior to randomization, with no planned or anticipated adjustments or dose changes to the stable treatment regimen\n\nExclusion Criteria:\n\n* Previous exposure to APL2\n* Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data\n* FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)\n* Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus\n* History of kidney transplant\n* Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses\n* Hypersensitivity to APL2 or to any of the excipients\n* Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results\n* Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period","ALL","18 Years",{"count":113,"type":114},270,"ESTIMATED","INTERVENTIONAL",[117,118],"PHASE2","PHASE3","This is a sequential phase 2\u002F3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.",[121],"FSGS",[123,124,125,126,127,128,129],"Glomerulosclerosis","Focal Segmental","Child","Adult","Peptides","Cyclic","Complement Inactivator Proteins","2026-08-31",{"date":132,"type":133},"2026-09-02","ACTUAL",{"date":135,"type":114},"2026-12",{"date":137,"type":114},"2029-12",{"name":5,"class":6},2]