Testing MIL62 for treating Primary Membranous Nephropathy

A Multicenter, Randomized, Controlled, Open Phase Ib/ Ⅱ Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nephropathy.

This study is testing a new treatment called MIL62 to see if it can help people with Primary Membranous Nephropathy feel better and improve their kidney function.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05398653 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of MIL62 in patients with Primary Membranous Nephropathy (pMN) through two phases. In Phase Ib, 30 subjects are randomly assigned to receive either MIL62 at doses of 600mg or 1000mg, or cyclosporine, with safety assessed over four weeks. If deemed tolerable, Phase II will further assess the efficacy of these treatments over a total of 104 weeks, focusing on the overall response rate at 76 weeks as the primary endpoint.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with Primary Membranous Nephropathy and exhibiting specific urinary protein levels.

Not a fit: Patients with secondary causes of Membranous Nephropathy or those resistant to cyclosporine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Primary Membranous Nephropathy.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for pMN have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Adult patients, ≥18 years of age;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
3. Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein \> 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
4. eGFR ≥40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m\^2 based on 24-hour urine collection during screening；
5. Sufficient organ function;
6. 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. Urine protein decreased by \> 50% within 6 months before screening；
4. Received treatment drugs for membranous nephropathy；
5. Concomitant with other serious diseases；
6. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
9. Other exclusion criteria may apply；

Where this trial is running

Beijing, Beijing

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

Study contacts

• Study coordinator: Minghui Zhao, doctor

Conditions: Primary Membranous Nephropathy