A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

NCT ID: NCT05862233

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2026-01-31

Brief Summary

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

Conditions

Primary Membranous Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIL62

Group Type: EXPERIMENTAL

MIL62

Intervention Type: DRUG

An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1 and Week 3.If the treatment is effective, MIL62 will continue be administered at W25 and W27

Cyclosporine

Group Type: ACTIVE_COMPARATOR

Cyclosporine

Intervention Type: DRUG

Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d in 2 divided 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.Optimized cyclosporine dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks.

Interventions

MIL62

An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1 and Week 3.If the treatment is effective, MIL62 will continue be administered at W25 and W27

Intervention Type: DRUG

Cyclosporine

Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d in 2 divided 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.Optimized cyclosporine dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks.

Intervention Type: DRUG

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. Screening 24-hour urinary protein >= 5 g after best supportive care for >= 3 months prior to screening or screening Screening 24-hour urinary protein > 3.5 g after best supportive care for >= 6 months prior to screening, or Screening 24-hour urinary protein > 3.5 g with at least one high-risk factor defined by the protocol;

4. Estimated glomerular filtration rate (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 (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug;

6. Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/or HBcAb-positive patients require regular HBV DNA testing); patients positive for hepatitis C virus (HCV) antibodies; or patients with a positive human immunodeficiency virus (HIV) serology.

7. Participants with CD4+ T lymphocyte count < 200 cells/μL;

8. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment;

9. Participants 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, , China

Countries

China

Other Identifiers

MIL62-CT307

Identifier Type: -

Identifier Source: org_study_id