A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

Last updated: August 14, 2025
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Idiopathic Membranous Nephropathy

Nephrotic Syndrome

Glomerulonephritis

Treatment

Cyclosporine

MIL62

Clinical Study ID

NCT05862233
MIL62-CT307
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80;

  2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior toor during screening;

  3. Screening 24-hour urinary protein >= 5 g after best supportive care for >= 3 monthsprior to screening or screening Screening 24-hour urinary protein > 3.5 g after bestsupportive care for >= 6 months prior to screening, or Screening 24-hour urinaryprotein > 3.5 g with at least one high-risk factor defined by the protocol;

  4. Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;

  5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptorblocker), 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 studyprotocol.

Exclusion

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), andparticipated in other clinical trials within 28 days prior to receiving the firststudy drug;

  6. Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis Bcore antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/orHBcAb-positive patients require regular HBV DNA testing); patients positive forhepatitis C virus (HCV) antibodies; or patients with a positive humanimmunodeficiency 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- tuberculosistreatment;

  9. Participants with known history of severe allergic reactions to humanized monoclonalantibodies, MIL62, or Cyclosporine

  10. Breastfeeding or pregnant women;

  11. Childbearing potential and unwillingness or impossibility to comply with ascientifically acceptable birth-control method

  12. Other conditions unsuitable for participation in this study determined by theInvestigator.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Cyclosporine
Phase: 3
Study Start date:
June 02, 2023
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.