Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT05862233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2023-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate at Week 76', 'timeFrame': 'Week 76', 'description': 'The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76.'}], 'secondaryOutcomes': [{'measure': 'Complete Remission rate at Week 52.', 'timeFrame': 'Week 52', 'description': 'The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints)'}, {'measure': 'Overall remission rate at Week 52 and 76.', 'timeFrame': 'Week 52 and 76', 'description': 'The proportion of participants who achieved overall remission(OR) based on UPCR at week 52 and week76.'}, {'measure': 'Complete remission rate and Overall remission rate at Week 24 and 104.', 'timeFrame': 'Week 24 and 104', 'description': 'The proportion of participants who achieved CR and OR based on UPCR at week 24 and week 104.'}, {'measure': 'Complete remission rate and Overall remission rate at Week 24，52，76 and 104.', 'timeFrame': 'Week 24，52，76 and 104', 'description': 'The proportion of participants who achieved CR or OR as assessed by the Investigators based on 24-hour urine protein at week 24, week 52, week 76 and week 104.'}, {'measure': 'Time to Treatment Failure or Relapse after Overall remission', 'timeFrame': 'Up to 104 weeks', 'description': 'Time to Treatment Failure or Relapse after Complete or Partial Remission'}, {'measure': 'Change in efficacy indicators', 'timeFrame': 'Baseline to Week 104', 'description': 'Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline to Week 104', 'description': 'Mean Change in T-score from Baseline in the EQ5D Scale at Week 104'}, {'measure': 'Percentage of Participants with Adverse Events (AEs)', 'timeFrame': 'up to 104 weeks', 'description': 'Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0'}, {'measure': 'Percentage of Participants with AEs of Special Interest (AESIs)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Peripheral B-cell Counts at Specified Timepoints', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Serum Concentrations of MIL62 at Specified Timepoints', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Incidence of ADAs during the study', 'timeFrame': 'Up to 104 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics（PD）and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80;\n2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;\n3. Screening 24-hour urinary protein \\>= 5 g after best supportive care for \\>= 3 months prior to screening or screening Screening 24-hour urinary protein \\> 3.5 g after best supportive care for \\>= 6 months prior to screening, or Screening 24-hour urinary protein \\> 3.5 g with at least one high-risk factor defined by the protocol;\n4. Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\\^2;\n5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;\n6. Sufficient organ function;\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Participants with a secondary cause of MN;\n2. Cyclosporine resistance;\n3. Received treatment drugs for membranous nephropathy;\n4. Concomitant with other serious diseases；\n5. Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug;\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/or HBcAb-positive patients require regular HBV DNA testing); patients positive for hepatitis C virus (HCV) antibodies; or patients with a positive human immunodeficiency virus (HIV) serology.\n7. Participants with CD4+ T lymphocyte count \\< 200 cells/μL;\n8. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment;\n9. Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine\n10. Breastfeeding or pregnant women;\n11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method\n12. Other conditions unsuitable for participation in this study determined by the Investigator.'}, 'identificationModule': {'nctId': 'NCT05862233', 'briefTitle': 'A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Mabworks Biotech Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy', 'orgStudyIdInfo': {'id': 'MIL62-CT307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIL62', 'interventionNames': ['Drug: MIL62']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine', 'interventionNames': ['Drug: Cyclosporine']}], 'interventions': [{'name': 'MIL62', 'type': 'DRUG', 'description': 'An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1 and Week 3.If the treatment is effective, MIL62 will continue be administered at W25 and W27', 'armGroupLabels': ['MIL62']}, {'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d in 2 divided doses, try to give every 12 hours.The dose was adjusted according to the blood concentration of cyclosporine monitored every 2 weeks±3 days until the target blood concentration of 125\\~175 ng/mL was reached.Optimized cyclosporine dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks.', 'armGroupLabels': ['Cyclosporine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Mabworks Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}