Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-09 @ 6:45 AM
Study NCT ID:
NCT06500702
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}], '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': 'D009401', 'term': 'Nephrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction in urine protein to creatinine ratio (UPCR)', 'timeFrame': 'From baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants achieving FSGS partial remission endpoint', 'timeFrame': 'At Week 12', 'description': 'Defined as UPCR ≤1.5 g/g and \\>40 % reduction of UPCR from baseline'}, {'measure': 'Percentage of participants achieving CR', 'timeFrame': 'At Week 12', 'description': 'Defined as UPCR ≤0.3 g/g'}, {'measure': 'Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study', 'timeFrame': 'Treatment emergent period, up to Week 48', 'description': 'TEAEs, including clinically significant changes in vital signs, electrocardiogram \\[ECG\\], and laboratory evaluation'}, {'measure': 'Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970', 'timeFrame': 'Up to Week 48'}, {'measure': 'Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970', 'timeFrame': 'Up to Week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focal Segmental Glomerulosclerosis', 'Glomerulonephritis Minimal Lesion']}, 'referencesModule': {'references': [{'pmid': '39899371', 'type': 'DERIVED', 'citation': 'Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=26033&tenant=MT_SNY_9011', 'label': 'ACT18064 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).\n\nThe purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.\n\nStudy details for each participant include:\n\nThe study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biopsy-proven primary FSGS or primary MCD.\n* UPCR ≥3 g/g at screening.\n* eGFR ≥45 mL/min/1.73 m\\^2 at screening.\n* Documented history of UPCR (or 24-hour urine protein) reduction by \\>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was 3.5 g/day if 24-hour urine protein is used).\n* ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.\n* On stable dose of RAAS for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.\n* On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.\n* Body weight within 45 to 120 kg (inclusive) at screening.\n\nExclusion Criteria:\n\n* Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.\n* Collapsing variant of FSGS.\n* ESKD requiring dialysis or transplantation.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06500702', 'acronym': 'RESULT', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)', 'orgStudyIdInfo': {'id': 'ACT18064'}, 'secondaryIdInfos': [{'id': '2024-511775-15', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1301-2676', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frexalimab', 'description': 'Frexalimab active dose', 'interventionNames': ['Drug: frexalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Brivekimig', 'description': 'Brivekimig active dose', 'interventionNames': ['Drug: brivekimig']}, {'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib', 'description': 'Rilzabrutinib active dose', 'interventionNames': ['Drug: rilzabrutinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'frexalimab', 'type': 'DRUG', 'description': 'frexalimab treatment', 'armGroupLabels': ['Frexalimab']}, {'name': 'brivekimig', 'type': 'DRUG', 'description': 'brivekimig treatment', 'armGroupLabels': ['Brivekimig']}, {'name': 'rilzabrutinib', 'type': 'DRUG', 'description': 'rilzabrutinib treatment', 'armGroupLabels': ['Rilzabrutinib']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site Number: 8400007', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site Number: 8400015', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site Number: 8400012', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 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'lon': 29.92928}}, {'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920002', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260001', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260004', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260005', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'contact-us@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}