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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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
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.
Peking University First Hospital
Beijing, China
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.
Time frame: Week 76
Complete Remission rate at Week 52.
The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 104 weeks
Change in efficacy indicators
Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB
Time frame: Baseline to Week 104
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Change in quality of life
Mean Change in T-score from Baseline in the EQ5D Scale at Week 104
Time frame: 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
Time frame: up to 104 weeks
Percentage of Participants with AEs of Special Interest (AESIs)
Time frame: Up to 104 weeks
Peripheral B-cell Counts at Specified Timepoints
Time frame: Up to 104 weeks
Serum Concentrations of MIL62 at Specified Timepoints
Time frame: Up to 104 weeks
Incidence of ADAs during the study
Time frame: Up to 104 weeks