A Clinical Study of MIL62 in Primary Membranous Nephropathy
Study Details
Study Description
Brief Summary
This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group. Tolerance to MIL62 was evaluated within 4 weeks after the first administration. If the overall safety is determined by the investigator and sponsor to be tolerable to MIL62, phase II enrollment will be initiated.
The second stage was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 30 subjects in each group, to evaluate the efficacy of MIL62 and cyclosporine in the treatment of primary membranous nephropathy. Eligible subjects in both phases received treatment and follow-up for a total of 104 weeks. The 76-week overall response rate was the primary endpoint.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MIL62
|
Drug: MIL62
An intravenous (IV) infusion of 600 mg of MIL62 will be administered at Week 1，Week 3.If the treatment is effective, MIL62 will continue be administered at W25，W27.
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| Active Comparator: Ciclosporin
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Drug: Cyclosporine
Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d, divided into 2 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.Cyclophosphamide will be maintained for 12 months, after which the dose was reduced by about 1/3 to 1/2 of the original dose each month, and discontinued after 2 months.
|
Outcome Measures
Primary Outcome Measures
- Stage 1: Percentage of Participants with Adverse Events [up to 2year after enrollment]
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
- Stage 2: Overall response rate (CR+PR) at Week 76 [Week 76]
Percentage of Participants with complete and partial response as assessed by the investigator.
Secondary Outcome Measures
- Stage 2: complete response, partial response, and overall response (CR+PR) at 104 weeks [Week 104]
Percentage of Participants with complete and partial response as assessed by the investigator.
- Stage 2: Complete response rate, partial response rate and overall response rate at 24 weeks and 52 weeks (CR+PR) [Week 52]
Percentage of Participants with complete 、partial response as assessed by the investigator.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients, ≥18 years of age;
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Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
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Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein > 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
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eGFR ≥40 mL/min/1.73m2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m2 based on 24-hour urine collection during screening；
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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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Urine protein decreased by > 50% within 6 months before screening；
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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;Central nervous system metastasis；
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Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
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Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
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Other exclusion criteria may apply；
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Beijing Mabworks Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIL62-CT206