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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

February 24, 2022

Primary Completion Date

March 4, 2025

Study Completion Date

April 18, 2025

Conditions
Primary Membranous Nephropathy
Interventions
DRUG

MIL62

An intravenous (IV) infusion of 600 mg of MIL62 will be administered at Week 1,Week 3.If the treatment is effective, MIL62 will continue be administered at W25,W27.

DRUG

Cyclosporine

Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d, divided into 2 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.Cyclophosphamide will be maintained for 12 months, after which the dose was reduced by about 1/3 to 1/2 of the original dose each month, and discontinued after 2 months.

Trial Locations (1)

100034

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY