Systemic Lupus ErythematosusPhase 3NCT07405970
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
A Phase 3 study testing MIL62 in people with Systemic Lupus Erythematosus, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MIL62
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
- Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
- High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
- On a stable dose of one or more standard treatments for SLE prior to the first administration；
- Able and willing to provide written informed consent and to comply with the study protocol.
Who cannot join
- Unsufficient organ function;
- Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- Subjects with CD4+ T lymphocyte count < 200 cells/μL;
- Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;
- Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
- TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;
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- Received live or attenuated vaccination within 28 days prior to the first administration;
- Participated in other clinical trials within 28 days prior to the first administration;
- Concomitant with other serious diseases;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);
- Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Zhanguo Li, Doctor, 8610-88324172, Zgli@aliyun.com
About this study
Official title: A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MIL62, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIL62Drug
MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1.
PlaceboDrug
Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1.
| Study group | Role | What they receive |
|---|---|---|
| MIL62 | Experimental | Not described Receives: Drug: MIL62 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving SRI-4 at Week 52
Measured: at Week 52
Secondary outcomes (9)
Proportion of participants achieving SRI-4 at Week 24
Measured: at Week 24
Changes in 24-hour urine protein in patients with baseline 24-hour urine protein elevation (24-hour urine protein ≥0.5g) at Week 24, 52
Measured: at Week 24,52
Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52
Measured: from Week 40 to Week 52 after randomization
Change From Baseline in EuroQol 5-Dimensional Questionnaire at Week 24, 52
EuroQol 5-Dimensional Questionnaire，the scale ranges from a minimum of 0 to a maximum of 100, where 100 represents the best imaginable health state and 0 represents the worst imaginable.
Measured: up to 52 weeks after randomization
Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM
Measured: up to 52 weeks after randomization
Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)
Measured: up to 52 weeks after randomization
Percentage of Participants with Adverse Events
Measured: up to 52 weeks after randomization
Pharmacodynamics(PD) characteristics: summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells
Measured: up to 52 weeks after randomization
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62
Measured: up to 52 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 316 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
- NCT07405970
- Sponsor's protocol ID
- MIL62-CT309
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT07405970
- Acronym / sponsor ID
- MIL62-CT309
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2026 (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 and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIL62 | Experimental | Drug: MIL62 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 ;
- Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
- Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
- High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
- On a stable dose of one or more standard treatments for SLE prior to the first administration；
Key exclusion criteria (14 listed)
- Unsufficient organ function;
- Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- Subjects with CD4+ T lymphocyte count < 200 cells/μL;
- Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;
- Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
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 |
|---|---|---|
| MIL62MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1. | Drug | MIL62 |
| PlaceboPlacebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1. | Drug | Placebo |
Primary outcome
Percentage of participants achieving SRI-4 at Week 52
Time frame: at Week 52
9 secondary outcomes
Proportion of participants achieving SRI-4 at Week 24
Time frame: at Week 24
Changes in 24-hour urine protein in patients with baseline 24-hour urine protein elevation (24-hour urine protein ≥0.5g) at Week 24, 52
Time frame: at Week 24,52
Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52
Time frame: from Week 40 to Week 52 after randomization
Change From Baseline in EuroQol 5-Dimensional Questionnaire at Week 24, 52
Time frame: up to 52 weeks after randomization
Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM
Time frame: up to 52 weeks after randomization
Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)
Time frame: up to 52 weeks after randomization
Percentage of Participants with Adverse Events
Time frame: up to 52 weeks after randomization
Pharmacodynamics(PD) characteristics: summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells
Time frame: up to 52 weeks after randomization
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62
Time frame: up to 52 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
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 in people with Systemic Lupus Erythematosus, 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 14 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhanguo Li (8610-88324172, Zgli@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving SRI-4 at Week 52 (time frame: at Week 52). 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 5 May 2026.