A Clinical Study of MIL62 in Primary Membranous Nephropathy
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MIL62
|
Drug: MIL62
An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1，Week 3.If the treatment is effective, MIL62 will continue be administered at W25，W27
|
| Active Comparator: Cyclosporine
|
Drug: Cyclosporine
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.If the treatment is effective,cyclosporine would be reduced by about 1/2 of the original dose each month, and discontinued after 2 months.
|
Outcome Measures
Primary Outcome Measures
- Overall Remission rate (CR+PR) at Week 52. [Week 52]
Percentage of Participants with complete and partial remission as assessed by the investigator.
- Overall Remission rate (CR+PR) at Week 76. [Week 76]
Percentage of Participants with complete and partial remission as assessed by the investigator.
Secondary Outcome Measures
- Complete Remission rate at Week 52. [Week 52]
Percentage of Participants with complete remission as assessed by the investigator.
- Complete Remission rate at Week 76. [Week 76]
Percentage of Participants with complete remission as assessed by the investigator.
- Overall Remission rate (CR+PR) at Week 24 [Week 24]
Percentage of Participants with complete and partial remission as assessed by the investigator.
- Overall Remission rate (CR+PR) at Week 104 [Week 104]
Percentage of Participants with complete and partial remission as assessed by the investigator.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-80;
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Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
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24 hours urinary protein > 3.5g at initial screening and confirmation assessment;
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Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;
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If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
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Sufficient organ function;
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Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion Criteria:
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Participants with a secondary cause of MN;
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Cyclosporine resistance;
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Received treatment drugs for membranous nephropathy;
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Concomitant with other serious diseases；
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Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;
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Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA );
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Subjects with CD4+ T lymphocyte count < 300 cells/μL;
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Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
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Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62，or Cyclosporine；
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Breastfeeding or pregnant women;
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Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
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Other conditions unsuitable for participation in this study determined by the Investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Mabworks Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIL62-CT307