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NCT Number: NCT05862233

A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Complete remission rate at Week 76

    Time frame: Week 76

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

Secondary outcomes

  1. Complete Remission rate at Week 52.

    Time frame: Week 52

    The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints)

  2. Overall remission rate at Week 52 and 76.

    Time frame: Week 52 and 76

    The proportion of participants who achieved overall remission(OR) based on UPCR at week 52 and week76.

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

    Time frame: Week 24 and 104

    The proportion of participants who achieved CR and OR based on UPCR at week 24 and week 104.

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

    Time frame: 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.

  5. Time to Treatment Failure or Relapse after Overall remission

    Time frame: Up to 104 weeks

    Time to Treatment Failure or Relapse after Complete or Partial Remission

  6. Change in efficacy indicators

    Time frame: Baseline to Week 104

    Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB

  7. Change in quality of life

    Time frame: Baseline to Week 104

    Mean Change in T-score from Baseline in the EQ5D Scale at Week 104

  8. Percentage of Participants with Adverse Events (AEs)

    Time frame: up to 104 weeks

    Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  9. Percentage of Participants with AEs of Special Interest (AESIs)

    Time frame: Up to 104 weeks

  10. Peripheral B-cell Counts at Specified Timepoints

    Time frame: Up to 104 weeks

  11. Serum Concentrations of MIL62 at Specified Timepoints

    Time frame: Up to 104 weeks

  12. Incidence of ADAs during the study

    Time frame: Up to 104 weeks

Sponsors and collaborators

Lead sponsor

Beijing Mabworks Biotech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 17, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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