Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07213960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR)', 'timeFrame': 'Baseline to Week 12', 'description': 'Change from Baseline in Log-Transformed uPCR will be based on triplicate first morning urine (FMU)'}, {'measure': 'Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR)', 'timeFrame': 'Baseline to Week 52', 'description': 'Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine albumin to creatinine ratio (uACR)', 'timeFrame': 'Baseline to Week 12', 'description': 'Change From Baseline in Log-Transformed uACR will be based on first morning urine (FMU)'}, {'measure': 'Phase 3: Change from Baseline in log-transformed urine protein to creatinine ratio (uPCR)', 'timeFrame': 'Baseline to Week 104', 'description': 'Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)'}, {'measure': 'Phase 3: Proportion of participants achieving Complete Remission', 'timeFrame': 'Week 104', 'description': 'Complete Remission is defined as participants who have achieved uPCR \\<0.3 g/g'}, {'measure': 'Phase 3: Slope of estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline to Week 104', 'description': 'The annualized eGFR slope'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glomerulosclerosis', 'Focal Segmental', 'Child', 'Adult', 'Peptides', 'Cyclic', 'Complement Inactivator Proteins'], 'conditions': ['FSGS']}, 'descriptionModule': {'briefSummary': 'This is a sequential phase 2/3 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g/g in at least 2 FMU samples collected during screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 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'}, 'identificationModule': {'nctId': 'NCT07213960', 'briefTitle': 'A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apellis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Sequential Phase 2/3, 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', 'orgStudyIdInfo': {'id': 'APL2-FSG-319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 - APL2', 'description': 'Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly', 'interventionNames': ['Drug: APL2']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3 - APL2', 'description': 'Adults: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly\n\nAdolescents:\n\n≥50 Kg: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly 35 to \\<50kg: First sub-cutaneous infusion of 648mg (12 mL) followed by 810mg (15 mL) every infusion thereafter (i.e. twice weekly) 30 to \\<35kg: First \\& Second sub-cutaneous infusion of 540mg (10mL) followed by 648mg (12 mL) every infusion thereafter (twice weekly)', 'interventionNames': ['Drug: APL2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 3 - Placebo', 'description': "Subcutaneous infusions of a sterile solution, twice-weekly, and equivalent in volume to the active arm based on participant's age and weight", 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'APL2', 'type': 'DRUG', 'description': 'Complement (C3) Inhibitor', 'armGroupLabels': ['Phase 2 - APL2', 'Phase 3 - APL2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Sterile solution of equal volume to active arm', 'armGroupLabels': ['Phase 3 - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60643', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Apellis Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@apellis.com', 'phone': '833-284-6361'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apellis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}