A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

Phase 3

Active, not recruiting

• Conditions: Primary Membranous Nephropathy
• Interventions: Drug: MIL62; Drug: Cyclosporine

• Registration Number: NCT05862233
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-17
• Study Start: 2023-06-02
• Status Verified: 2024-10
• Primary Completion: 2025-05-13
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-20
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIL62	MIL62	-
Cyclosporine	Cyclosporine	-
MIL62	MIL62	-
Cyclosporine	Cyclosporine	-

Primary Outcome Measures

Name	Time	Method
Complete remission rate at Week 76	Week 76	The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76.

Secondary Outcome Measures

Name	Time	Method
Complete Remission rate at Week 52.	Week 52	The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints)
Complete remission rate and Overall remission rate at Week 24 and 104.	Week 24 and 104	The proportion of participants who achieved CR and OR based on UPCR at week 24 and week 104.
Complete remission rate and Overall remission rate at Week 24，52，76 and 104.	Week 24，52，76 and 104	The proportion of participants who achieved CR or OR as assessed by the Investigators based on 24-hour urine protein at week 24, week 52, week 76 and week 104.
Time to Treatment Failure or Relapse after Overall remission	Up to 104 weeks	Time to Treatment Failure or Relapse after Complete or Partial Remission
Change in efficacy indicators	Baseline to Week 104	Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB
Overall remission rate at Week 52 and 76.	Week 52 and 76	The proportion of participants who achieved overall remission(OR) based on UPCR at week 52 and week76.
Change in quality of life	Baseline to Week 104	Mean Change in T-score from Baseline in the EQ5D Scale at Week 104
Percentage of Participants with Adverse Events (AEs)	up to 104 weeks	Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Percentage of Participants with AEs of Special Interest (AESIs)	Up to 104 weeks
Peripheral B-cell Counts at Specified Timepoints	Up to 104 weeks
Serum Concentrations of MIL62 at Specified Timepoints	Up to 104 weeks
Incidence of ADAs during the study	Up to 104 weeks

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China