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ACTIVE NOT RECRUITING

NCT05862233

PHASE3

A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy

Sponsor: Beijing Mabworks Biotech Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-06-02

Completion Date

2026-01

Last Updated

2025-08-20

Healthy Volunteers

Conditions

Primary Membranous Nephropathy

Interventions

DRUG

MIL62

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

DRUG

Cyclosporine

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.

Inclusion Criteria: 1. Age 18-80; 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 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. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), 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 study protocol. 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), and participated in other clinical trials within 28 days prior to receiving the first study drug; 6. 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. 7. Participants with CD4+ T lymphocyte count \< 200 cells/μL; 8. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment; 9. Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine 10. Breastfeeding or pregnant women; 11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method 12. Other conditions unsuitable for participation in this study determined by the Investigator.

Locations (1)

Peking University First Hospital

Beijing, China