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A Clinical Study of MIL62 in Primary Membranous Nephropathy

Primary Purpose

Primary Membranous Nephropathy

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MIL62
Cyclosporine
Sponsored by
Beijing Mabworks Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Membranous Nephropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80; Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening; 24 hours urinary protein > 3.5g at initial screening and confirmation assessment; Epidermal growth factor receptor (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 (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA ); Subjects with CD4+ T lymphocyte count < 300 cells/μL; Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment; Subjects 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.

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIL62

Cyclosporine

Arm Description

Outcomes

Primary Outcome Measures

Overall Remission rate (CR+PR) at Week 52.
Percentage of Participants with complete and partial remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 76.
Percentage of Participants with complete and partial remission as assessed by the investigator.

Secondary Outcome Measures

Complete Remission rate at Week 52.
Percentage of Participants with complete remission as assessed by the investigator.
Complete Remission rate at Week 76.
Percentage of Participants with complete remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 24
Percentage of Participants with complete and partial remission as assessed by the investigator.
Overall Remission rate (CR+PR) at Week 104
Percentage of Participants with complete and partial remission as assessed by the investigator.

Full Information

First Posted
May 8, 2023
Last Updated
August 9, 2023
Sponsor
Beijing Mabworks Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05862233
Brief Title
A Clinical Study of MIL62 in Primary Membranous Nephropathy
Official Title
A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Mabworks Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies(ADA) of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Membranous Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIL62
Arm Type
Experimental
Arm Title
Cyclosporine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MIL62
Intervention Description
An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at Week 1,Week 3.If the treatment is effective, MIL62 will continue be administered at W25,W27
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
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.If the treatment is effective,cyclosporine would be reduced by about 1/2 of the original dose each month, and discontinued after 2 months.
Primary Outcome Measure Information:
Title
Overall Remission rate (CR+PR) at Week 52.
Description
Percentage of Participants with complete and partial remission as assessed by the investigator.
Time Frame
Week 52
Title
Overall Remission rate (CR+PR) at Week 76.
Description
Percentage of Participants with complete and partial remission as assessed by the investigator.
Time Frame
Week 76
Secondary Outcome Measure Information:
Title
Complete Remission rate at Week 52.
Description
Percentage of Participants with complete remission as assessed by the investigator.
Time Frame
Week 52
Title
Complete Remission rate at Week 76.
Description
Percentage of Participants with complete remission as assessed by the investigator.
Time Frame
Week 76
Title
Overall Remission rate (CR+PR) at Week 24
Description
Percentage of Participants with complete and partial remission as assessed by the investigator.
Time Frame
Week 24
Title
Overall Remission rate (CR+PR) at Week 104
Description
Percentage of Participants with complete and partial remission as assessed by the investigator.
Time Frame
Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80; Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening; 24 hours urinary protein > 3.5g at initial screening and confirmation assessment; Epidermal growth factor receptor (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 (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA ); Subjects with CD4+ T lymphocyte count < 300 cells/μL; Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment; Subjects 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minghui Zhao, Doctor
Phone
8610-83572388
Email
mhzhao@bjmu.edu.cn
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghui Zhao, Doctor
Phone
8610-83572388
Email
mhzhao@bjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Clinical Study of MIL62 in Primary Membranous Nephropathy

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