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Systemic Lupus ErythematosusPhase 2NCT05796206

A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus

A Phase 2 study testing MIL62 in people with Systemic Lupus Erythematosus, 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
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Trial summary

This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA 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
123 participants
Where
1 siteChina
Study dates
26 May 2023to 2 Jul 2026
Phase
Phase 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 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 ;
  • Low C3 and/or low C4 complement at screening ;
  • High disease activity at screening ;
  • On a stable SLE treatment regimen for at least 30 days 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 12 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;
  • Received live or attenuated vaccination within 28 days prior to the first administration;
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  • 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.

China1 site

  • Peking University People's Hospital

    Beijing

Other trials in China

About this study

Official title: A Phase 2 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, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with 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, W53D1, and W55D1.

  • placeboDrug

    Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1.

Study groups in NCT05796206
Study groupRoleWhat they receive
MIL62(Part A and B)ExperimentalNot described
Receives: Drug: MIL62
Placebo (Part A and B)Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Part A and Part B:Percentage of participants achieving SRI-4 at Week 12

    Measured: at Week 12

Secondary outcomes (13)

  1. Part A and Part B:Proportion of participants achieving SRI-4 at Week 52

    Measured: at Week 52

  2. Part A and Part B:Proportion of participants achieving SRI-4 at Week 24

    Measured: at Week 24

  3. Part A and Part B:Proportion of participants achieving SRI-4 at Week76

    Measured: at Week 76

  4. Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76

    Measured: up to 76 weeks after randomization

  5. Part A and Part B: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

  6. Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 24, 52, 76

    Measured: up to 76 weeks after randomization

  7. Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM

    Measured: up to 76 weeks after randomization

  8. Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)

    Measured: up to 76 weeks after randomization

  9. Part A and Part B:Percentage of Participants with Adverse Events

    Measured: up to 76 weeks after randomization

  10. Part A: Pharmacokinetic(PK) Parameters: AUC

    The area under the curve (AUC) of serum concentration of the drug after the administration

    Measured: up to 76 weeks after randomization

  11. Part A: Pharmacokinetic(PK) Parameters:Cmax

    Maximum concentration(Cmax) of the drug after administration

    Measured: up to 76 weeks after randomization

  12. Part A and Part B: Pharmacodynamics(PD) characteristics：summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells, CD3⁺CD4⁺ T cells, CD3⁺CD8⁺ T cells, NK cells, CD19⁺CD27⁺ B cells, and CD19⁺CD27- naïve B cells

    Measured: up to 76 weeks after randomization

  13. Part Aand Part B: Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62

    Measured: up to 76 weeks after randomization

Timeline

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

  1. First posted3 Apr 2023
  2. Study start26 May 2023
  3. Primary completion21 Nov 2024
  4. Study completion2 Jul 2026

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796206
Sponsor's protocol ID
MIL62-CT308
Status last verified
Dec 2025
First submitted
8 Mar 2023
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 7 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 2 Nov 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 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?

Part A and Part B:Percentage of participants achieving SRI-4 at Week 12 (time frame: at Week 12). 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 NCT05796206.

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 2 Nov 2026.

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