NCT05862233

A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Beijing Mabworks Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	MIL62	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
DRUG	Cyclosporine	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.

Timeline

• Start date: 2023-06-02
• Primary completion: 2025-05-13
• Completion: 2026-01-01
• First posted: 2023-05-17
• Last updated: 2025-08-20

Locations

1 site across 1 country: China