Evaluating MIL62 for treating Primary Membranous Nephropathy

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

This study is testing if a new treatment called MIL62 can work better and be safer than cyclosporine for adults with primary membranous nephropathy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT05862233 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy and safety of MIL62 compared to cyclosporine in patients diagnosed with primary membranous nephropathy. Participants will undergo evaluations of pharmacokinetics, pharmacodynamics, and the presence of anti-drug antibodies. The study will include adults aged 18 to 80 who meet specific eligibility criteria related to their kidney function and protein levels. The goal is to determine if MIL62 offers a more effective treatment option for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a confirmed diagnosis of primary membranous nephropathy and significant proteinuria.

Not a fit: Patients with secondary causes of membranous nephropathy or those who have previously shown resistance to cyclosporine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new and potentially more effective treatment option for patients with primary membranous nephropathy.

How similar studies have performed: While this approach is focused on a specific treatment, similar studies evaluating new therapies for membranous nephropathy have shown promise, indicating potential for success.

Eligibility 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. 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.

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Minghui Zhao, Doctor

Conditions Primary Membranous Nephropathy