A Clinical Study of MIL62 in Primary Membranous Nephropathy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05398653
Study type	Interventional
Source	Beijing Mabworks Biotech Co., Ltd.
Contact	Minghui Zhao, doctor
Phone	8610-83572388
Email	mhzhao@bjmu.edu.cn
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	February 24, 2022
Completion date	October 2025

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