AzTrials
AzTrials

Primary Membranous NephropathyPhase 1/2NCT05398653

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

A Phase 1/2 study testing MIL62 and Cyclosporine in people with Primary Membranous Nephropathy, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Membranous Nephropathy
What is being tested?
MIL62 and Cyclosporine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
24 Feb 2022to 18 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official 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.

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.

Being tested
MIL62, Cyclosporine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIL62Drug

    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.

  • CyclosporineDrug

    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.

  • MIL62Drug

    A 1000 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.

Study groups in NCT05398653
Study groupRoleWhat they receive
MIL62(600mg)ExperimentalNot described
Receives: Drug: MIL62
CiclosporinActive comparatorNot described
Receives: Drug: Cyclosporine
MIL62(1000mg)ExperimentalNot described
Receives: Drug: MIL62

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage 1: The Tolerability and Safety of MIL62 in Participants with Primary Membranous Nephropathy

    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.

    Measured: up to 2 year after enrollment

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

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

    Measured: Week 12

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

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

    Measured: week 24

Secondary outcomes (17)

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

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

    Measured: Week 24, 52, 76 and 104

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

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

    Measured: Week 24

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

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

    Measured: Week 52, 76, 104

  4. Stage 2: Time to CR and OR

    Measured: up to 104 weeks

  5. Stage 2:The duration of CR and OR

    Measured: up to 104 weeks

  6. Stage 2: Change in anti-PLA2R antibody

    Measured: up to 104 weeks

  7. Stage 2: Change in eGFR

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

  9. Stage 2: Percentage of Participants with Adverse Events (AEs)

    Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

  12. Stage 2: Incidence of ADAs during the study

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

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

    Measured: up to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start24 Feb 2022
  3. Primary completion4 Mar 2025
  4. Study completion18 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398653
Sponsor's protocol ID
MIL62-CT206
Status last verified
Sep 2025
First submitted
26 May 2022
Last updated
17 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MIL62 and Cyclosporine in people with Primary Membranous Nephropathy, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: The Tolerability and Safety of MIL62 in Participants with Primary Membranous Nephropathy (time frame: up to 2 year after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in