A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

NCT05862233 | Active Not Recruiting Phase 3

• 1 other identifier: MIL62-CT307
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete remission rate at Week 76

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

  Week 76

Secondary Outcomes (12)

• Complete Remission rate at Week 52.

  Week 52

• Overall remission rate at Week 52 and 76.

  Week 52 and 76

• Complete remission rate and Overall remission rate at Week 24 and 104.

  Week 24 and 104

• Complete remission rate and Overall remission rate at Week 24，52，76 and 104.

  Week 24，52，76 and 104

• Time to Treatment Failure or Relapse after Overall remission

  Up to 104 weeks

Study Arms (2)

MIL62

EXPERIMENTAL

Drug: MIL62

Cyclosporine

ACTIVE COMPARATOR

Drug: Cyclosporine

Interventions

MIL62 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

MIL62

Cyclosporine 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.

Cyclosporine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80;
• Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
• 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;
• Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2;
• If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
• Sufficient organ function;
• Able and willing to provide written informed consent and to comply with the study protocol.

You may not qualify if:

• Participants with a secondary cause of MN;
• Cyclosporine resistance;
• Received treatment drugs for membranous nephropathy;
• Concomitant with other serious diseases；
• Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug;
• 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.
• Participants with CD4+ T lymphocyte count \< 200 cells/μL;
• Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment;
• Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine
• Breastfeeding or pregnant women;
• Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
• Other conditions unsuitable for participation in this study determined by the Investigator.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: June 2, 2023
• Primary Completion: May 13, 2025
• Study Completion: January 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2024-10

Locations

CN (1)