Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 3:30 AM
Study NCT ID:
NCT06419205
Status:
WITHDRAWN
Last Update Posted:
2025-04-20
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'C565169', 'term': 'Complement Component 3 Deficiency, Autosomal Recessive'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study closed prior to enrolling any patients.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-13', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) to evaluate the safety of ADX-097', 'timeFrame': '42 weeks', 'description': 'Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in urine protein-to-creatinine ratio (uPCR)', 'timeFrame': '26 weeks', 'description': 'To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G'}, {'measure': 'Change from baseline in estimated glomerular filtration rate (eGFR)', 'timeFrame': '26 weeks', 'description': 'To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy', 'Lupus Nephritis (LN)', 'C3 (Complement Component 3) Glomerulopathy']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female participants aged ≥18 years.\n2. Urine protein ≥ 0.75 g/24 hours or uPCR ≥ 0.5g/g\n3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).\n4. Participants receiving a RAAS inhibitor must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.\n5. Participants receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor or sparsentan must have been on a stable dose for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.\n6. Kidney biopsy-proven diagnosis of IgAN within 52 week; LN within 12 weeks or C3G within 52 weeks of Day 1 and with evidence of C3 fragment deposition.\n\nKey Exclusion Criteria\n\n1. A ≥50% decline in eGFR within 3 months before screening.\n2. Concomitant significant renal disease other than IgAN, C3G, or LN.\n3. Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment.\n4. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.'}, 'identificationModule': {'nctId': 'NCT06419205', 'briefTitle': 'A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G', 'organization': {'class': 'INDUSTRY', 'fullName': 'Q32 Bio Inc.'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With IgAN, LN, or C3G', 'orgStudyIdInfo': {'id': 'ADX-097-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open Label', 'description': 'Subcutaneous Infusions', 'interventionNames': ['Drug: ADX-097']}], 'interventions': [{'name': 'ADX-097', 'type': 'DRUG', 'description': 'Open Label', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '00000', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '00000', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '00000', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '00000', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Q32 Bio Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}