A Clinical Study of MIL62 in Primary Membranous Nephropathy

Study Overview
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Brief Summary
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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).

Official Title
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A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy

Conditions
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Primary Membranous Nephropathy

Intervention / Treatment
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* Drug: MIL62
* Drug: Cyclosporine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80; Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening; 24 hours urinary protein > 3.5g at initial screening and confirmation assessment; Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2; If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required; Sufficient organ function; Able and willing to provide written informed consent and to comply with the study protocol. Exclusion Criteria: Participants with a secondary cause of MN; Cyclosporine resistance; Received treatment drugs for membranous nephropathy; Concomitant with other serious diseases； Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA ); Subjects with CD4+ T lymphocyte count < 300 cells/μL; Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment; Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62，or Cyclosporine； Breastfeeding or pregnant women; Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method Other conditions unsuitable for participation in this study determined by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIL62<br> | Drug: MIL62<br>* 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<br>|
| Active Comparator: Cyclosporine<br> | Drug: Cyclosporine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Remission rate (CR+PR) at Week 52. | Percentage of Participants with complete and partial remission as assessed by the investigator. | Week 52 | 
| Overall Remission rate (CR+PR) at Week 76. | Percentage of Participants with complete and partial remission as assessed by the investigator. | Week 76 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission rate at Week 52. | Percentage of Participants with complete remission as assessed by the investigator. | Week 52 | 
| Complete Remission rate at Week 76. | Percentage of Participants with complete remission as assessed by the investigator. | Week 76 | 
| Overall Remission rate (CR+PR) at Week 24 | Percentage of Participants with complete and partial remission as assessed by the investigator. | Week 24 | 
| Overall Remission rate (CR+PR) at Week 104 | Percentage of Participants with complete and partial remission as assessed by the investigator. | Week 104 |