A Clinical Study of MIL62 in Primary Membranous Nephropathy
Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
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.