CompletedPhase 1/2

A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy

China94 participantsStarted 2022-02-24

Plain-language 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(Phase II) was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 20 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 primary efficacy endpoints were the 12-week immune remission rate and the 24-week overall remission rate.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult patients, ≥18 years of age;
✓. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
✓. Screening 24-hour urinary protein \>= 5 g after best supportive care for \>= 3 months prior to screening or screening 24-hour urinary protein \> 3.5 g after best supportive care for \>= 6 months prior to screening, or Screening 24-hour urinary protein \> 3.5 g with at least one high-risk factor defined by the protocol;
✓. Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2；
✓. 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
✕. Urine protein decreased by \> 50% within 6 months before screening

What they're measuring

Stage 1: The Tolerability and Safety of MIL62 in Participants with Primary Membranous Nephropathy

Timeframe: up to 2 year after enrollment

Stage 1 and Stage 2: The 12-week immune remission rate in the anti-PLA2R antibody-positive population.

Timeframe: Week 12

Stage 1 and Stage 2:The 24-week overall remission rate (ORR)

Timeframe: week 24

Trial details

NCT IDNCT05398653

SponsorBeijing Mabworks Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-04

View on ClinicalTrials.gov More Primary Membranous Nephropathy trials