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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62 | Experimental |
| |
| Cyclosporine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIL62 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate at Week 76 | The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76. | Week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission rate at Week 52. | The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints) | Week 52 |
| Overall remission rate at Week 52 and 76. | The proportion of participants who achieved overall remission(OR) based on UPCR at week 52 and week76. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Cyclosporine | Drug | 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. |
|
| Week 52 and 76 |
| Complete remission rate and Overall remission rate at Week 24 and 104. | The proportion of participants who achieved CR and OR based on UPCR at week 24 and week 104. | Week 24 and 104 |
| Complete remission rate and Overall remission rate at Week 24,52,76 and 104. | 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. | Week 24,52,76 and 104 |
| Time to Treatment Failure or Relapse after Overall remission | Time to Treatment Failure or Relapse after Complete or Partial Remission | Up to 104 weeks |
| Change in efficacy indicators | Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB | Baseline to Week 104 |
| Change in quality of life | Mean Change in T-score from Baseline in the EQ5D Scale at Week 104 | Baseline to Week 104 |
| Percentage of Participants with Adverse Events (AEs) | Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | up to 104 weeks |
| Percentage of Participants with AEs of Special Interest (AESIs) | Up to 104 weeks |
| Peripheral B-cell Counts at Specified Timepoints | Up to 104 weeks |
| Serum Concentrations of MIL62 at Specified Timepoints | Up to 104 weeks |
| Incidence of ADAs during the study | Up to 104 weeks |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |