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

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.

NCT05398653•Beijing Mabworks Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult patients, ≥18 years of age;
•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 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. Sufficient organ function;
•6. 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. Urine protein decreased by \> 50% within 6 months before screening
•4. Received treatment drugs for membranous nephropathy
•5. Concomitant with other serious diseases
•6. Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug
•7. 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
•8. Participants with CD4+ T lymphocyte count \< 300 cells/μL
•9. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment
•10. Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine
+3 more criteria

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 24, 2022

Primary Completion Date

March 4, 2025

Completion Date

April 18, 2025

Last Updated

November 17, 2025

Enrollment

ACTUAL participants

Conditions

Primary Membranous Nephropathy

Interventions

MIL62

DRUG

Cyclosporine

DRUG

MIL62

DRUG

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RECRUITINGPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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