Primary Membranous NephropathyPhase 3NCT05862233
A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy
A Phase 3 study testing MIL62 and Cyclosporine in people with Primary Membranous Nephropathy, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- MIL62 and Cyclosporine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2023to Jan 2026
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80;
- 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 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;
- 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.
Who cannot join
- 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 (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.
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- Participants with CD4+ T lymphocyte count < 200 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.
About this study
Official title: A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy
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).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- MIL62, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIL62Drug
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
CyclosporineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MIL62 | Experimental | Not described Receives: Drug: MIL62 |
| Cyclosporine | Active comparator | Not described Receives: Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate at Week 76
The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76.
Measured: Week 76
Secondary outcomes (12)
Complete Remission rate at Week 52.
The proportion of participants who achieved CR based on UPCR at week52 (key secondary endpoints)
Measured: Week 52
Overall remission rate at Week 52 and 76.
The proportion of participants who achieved overall remission(OR) based on UPCR at week 52 and week76.
Measured: Week 52 and 76
Complete remission rate and Overall remission rate at Week 24 and 104.
The proportion of participants who achieved CR and OR based on UPCR at week 24 and week 104.
Measured: Week 24 and 104
Complete remission rate and Overall remission rate at Week 24，52，76 and 104.
The proportion of participants who achieved CR or OR as assessed by the Investigators based on 24-hour urine protein at week 24, week 52, week 76 and week 104.
Measured: Week 24，52，76 and 104
Time to Treatment Failure or Relapse after Overall remission
Time to Treatment Failure or Relapse after Complete or Partial Remission
Measured: Up to 104 weeks
Change in efficacy indicators
Change in anti-PLA2R Autoantibody Titer, UPCR, eGFR, 24-hour urine protein and ALB
Measured: Baseline to Week 104
Change in quality of life
Mean Change in T-score from Baseline in the EQ5D Scale at Week 104
Measured: Baseline to Week 104
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
Percentage of Participants with AEs of Special Interest (AESIs)
Measured: Up to 104 weeks
Peripheral B-cell Counts at Specified Timepoints
Measured: Up to 104 weeks
Serum Concentrations of MIL62 at Specified Timepoints
Measured: Up to 104 weeks
Incidence of ADAs during the study
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.
- First posted17 May 2023
- Study start2 Jun 2023
- Primary completion13 May 2025
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862233
- Sponsor's protocol ID
- MIL62-CT307
- Status last verified
- Oct 2024
- First submitted
- 8 May 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT05862233
- Acronym / sponsor ID
- MIL62-CT307
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIL62 | Experimental | Drug: MIL62 |
| Cyclosporine | Active comparator | Drug: Cyclosporine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80;
- 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 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;
- If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
Key exclusion criteria (12 listed)
- 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 (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIL62An 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 | MIL62 |
| CyclosporineParticipants 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. | Drug | Cyclosporine |
Primary outcome
Complete remission rate at Week 76
Time frame: Week 76
The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76.
12 secondary outcomes
Complete Remission rate at Week 52.
Time frame: Week 52
Overall remission rate at Week 52 and 76.
Time frame: Week 52 and 76
Complete remission rate and Overall remission rate at Week 24 and 104.
Time frame: Week 24 and 104
Complete remission rate and Overall remission rate at Week 24，52，76 and 104.
Time frame: Week 24，52，76 and 104
Time to Treatment Failure or Relapse after Overall remission
Time frame: Up to 104 weeks
Change in efficacy indicators
Time frame: Baseline to Week 104
Change in quality of life
Time frame: Baseline to Week 104
Percentage of Participants with Adverse Events (AEs)
Time frame: up to 104 weeks
Percentage of Participants with AEs of Special Interest (AESIs)
Time frame: Up to 104 weeks
Peripheral B-cell Counts at Specified Timepoints
Time frame: Up to 104 weeks
Serum Concentrations of MIL62 at Specified Timepoints
Time frame: Up to 104 weeks
Incidence of ADAs during the study
Time frame: Up to 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Aug 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Complete remission rate at Week 76 (time frame: Week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.