A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

Phase 3

Active, not recruiting

• Conditions: Primary Membranous Nephropathy
• Interventions: Drug: MIL62; Drug: Cyclosporine

• Registration Number: NCT05862233
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

Brief Summary

This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-17
• Study Start: 2023-06-02
• Status Verified: 2024-10
• Primary Completion: 2025-05-13
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 18-80;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
3. 24 hours urinary protein > 3.5g at initial screening and confirmation assessment;
4. Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Sufficient organ function;
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria

1. Participants with a secondary cause of MN;
2. Cyclosporine resistance;
3. Received treatment drugs for membranous nephropathy;
4. Concomitant with other serious diseases；
5. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;
6. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA );
7. Subjects with CD4+ T lymphocyte count < 300 cells/μL;
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
9. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62，or Cyclosporine；
10. Breastfeeding or pregnant women;
11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
12. Other conditions unsuitable for participation in this study determined by the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIL62	MIL62	-
Cyclosporine	Cyclosporine	-

Primary Outcome Measures

Name	Time	Method
Overall Remission rate (CR+PR) at Week 52.	Week 52	Percentage of Participants with complete and partial remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 76.	Week 76	Percentage of Participants with complete and partial remission as assessed by the investigator.

Secondary Outcome Measures

Name	Time	Method
Complete Remission rate at Week 52.	Week 52	Percentage of Participants with complete remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 24	Week 24	Percentage of Participants with complete and partial remission as assessed by the investigator.
Complete Remission rate at Week 76.	Week 76	Percentage of Participants with complete remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 104	Week 104	Percentage of Participants with complete and partial remission as assessed by the investigator.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China