A Clinical Study of MIL62 in Primary Membranous Nephropathy

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.
• Treatments: Cyclosporine; Cyclosporins

Criteria

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. 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.