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Completed

NCT Number: NCT05398653

A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy

This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group. Tolerance to MIL62 was evaluated within 4 weeks after the first administration. If the overall safety is determined by the investigator and sponsor to be tolerable to MIL62, phase II enrollment will be initiated.

The second stage(Phase II) was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 20 subjects in each group, to evaluate the efficacy of MIL62 and cyclosporine in the treatment of primary membranous nephropathy. Eligible subjects in both phases received treatment and follow-up for a total of 104 weeks. The primary efficacy endpoints were the 12-week immune remission rate and the 24-week overall remission rate.

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Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, ≥18 years of age;
  • 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 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；
  • 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
  • Urine protein decreased by > 50% within 6 months before screening
  • 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 < 300 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

A 600 mg intravenous (IV) infusion of MIL62 will be administered on Week 1 Day 1 and Week 3 Day 1. If treatment response is observed, additional doses will be administered on Week 25 Day 1 and Week 27 Day 1. According to the protocol amendment in June 2023, some patients also received MIL62 treatment on Week 53 Day 1.

cyclosporine

Drug

Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d, divided into 2 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. Stage 1: The Tolerability and Safety of MIL62 in Participants with Primary Membranous Nephropathy

    Time frame: up to 2 year after enrollment

    Evaluation of the Tolerability and Safety of MIL62 in Participants with pMN.The tolerance is defined as the occurrence of CTCAE 5.0 Grade ≥3 adverse events within 28 days after the first dose of MIL62.Safety assessments included adverse events, vital signs, physical examinations, laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status and 12-lead electrocardiograms (ECG) during the study period.

  2. Stage 1 and Stage 2: The 12-week immune remission rate in the anti-PLA2R antibody-positive population.

    Time frame: Week 12

    The proportion of participants who achieved immune remission(Anti-PLA2R antibody<14RU/mL) at week 12.

  3. Stage 1 and Stage 2:The 24-week overall remission rate (ORR)

    Time frame: week 24

    The proportion of participants who achieved overall remission (complete and partial remission) at week 24.

Secondary outcomes

  1. Stage 2: The immune remission rate at week 24, 52, 76, and 104.

    Time frame: Week 24, 52, 76 and 104

    The proportion of participants who achieved immune remissionat week 24, 52, 76, 104.

  2. Stage 2: The complete remission rate (CRR) and partial remission rate (PRR) at week 24.

    Time frame: Week 24

    The proportion of participants who achieved complete remission (CR) and partial remission (PR) at week 24.

  3. Stage 2:The CRR, PRR and ORR at week 52, 76, 104.

    Time frame: Week 52, 76, 104

    The proportion of participants who achieved CR、PR and overall remission (OR) at week 52,76,104.

  4. Stage 2: Time to CR and OR

    Time frame: up to 104 weeks

  5. Stage 2:The duration of CR and OR

    Time frame: up to 104 weeks

  6. Stage 2: Change in anti-PLA2R antibody

    Time frame: up to 104 weeks

  7. Stage 2: Change in eGFR

    Time frame: up to 104 weeks

  8. Stage 2: Change in 24-hour urine protein

    Time frame: up to 104 weeks

  9. Stage 2: 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

  10. Stage 2: Percentage of participants with AEs of Special Interest (AESIs)

    Time frame: up to 104 weeks

  11. Stage 2: Peripheral B-cell Counts at Specified Timepoints.

    Time frame: up to 104 weeks

  12. Stage 2: Incidence of ADAs during the study

    Time frame: up to 104 weeks

  13. Stage 2: Pharmacokinetic(PK) Parameters during the study: Area Under the Curve(AUC)

    Time frame: up to 104 weeks

  14. Stage 2: Pharmacokinetic(PK) Parameters during the study:Maximum Concentration(Cmax)

    Time frame: up to 104 weeks

  15. Stage 2: Pharmacokinetic(PK) Parameters during the study: t1/2

    Time frame: up to 104 weeks

  16. Stage 2: Pharmacokinetic(PK) Parameters during the study: Volume of Distribution (Vd)

    Time frame: up to 104 weeks

  17. Stage 2: Pharmacokinetic(PK) Parameters during the study: Clearance(CL)

    Time frame: up to 104 weeks

Sponsors and collaborators

Lead sponsor

Beijing Mabworks Biotech Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Controlled, Open Phase Ib/ Ⅱ Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nephropathy.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Nov 17, 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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