A Clinical Study of MIL62 in Primary Membranous Nephropathy

Primary Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862233
• Other study ID #: MIL62-CT307
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Minghui Zhao, Doctor
• Phone: 8610-83572388
• Email: mhzhao[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Diseases
• Primary Membranous Nephropathy

Intervention

Drug:
• MIL62
An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1,Week 3.If the treatment is effective, MIL62 will continue be administered at W25,W27
• 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.If the treatment is effective,cyclosporine would be reduced by about 1/2 of the original dose each month, and discontinued after 2 months.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Remission rate (CR+PR) at Week 52.	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 52
Primary	Overall Remission rate (CR+PR) at Week 76.	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 76
Secondary	Complete Remission rate at Week 52.	Percentage of Participants with complete remission as assessed by the investigator.	Week 52
Secondary	Complete Remission rate at Week 76.	Percentage of Participants with complete remission as assessed by the investigator.	Week 76
Secondary	Overall Remission rate (CR+PR) at Week 24	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 24
Secondary	Overall Remission rate (CR+PR) at Week 104	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 104