A Clinical Study of MIL62 in 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 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).

Study Overview

• Status: Recruiting
• Conditions: Primary Membranous Nephropathy
• Intervention / Treatment: Drug: MIL62; Drug: Cyclosporine

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Minghui Zhao, doctor; Phone Number: 8610-83572388; Email: mhzhao@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University first hospital
    • Contact: Minghui Zhao, doctor; Phone Number: 8610-83572388; Email: mhzhao@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIL62	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
Active Comparator: Cyclosporine	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.If the treatment is effective,cyclosporine would be reduced by about 1/2 of the original dose each month, and discontinued after 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Remission rate (CR+PR) at Week 52.	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 52
Overall Remission rate (CR+PR) at Week 76.	Percentage of Participants with complete and partial remission as assessed by the investigator.	Week 76

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Mabworks Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, Membranous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: MIL62-CT307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No