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Active, not recruitingNCT05796206Updated Dec 19, 2025

A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus

A Phase 2 interventional study of MIL62 and placebo in Systemic Lupus Erythematosus, sponsored by Beijing Mabworks Biotech Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Beijing Mabworks Biotech Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 120 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Beijing Mabworks Biotech Co., Ltd. is the lead sponsor of 17 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-80 ;
  2. Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
  3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
  4. Low C3 and/or low C4 complement at screening ;
  5. High disease activity at screening ;
  6. On a stable SLE treatment regimen for at least 30 days prior to the first administration；
  7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Unsufficient organ function;
  2. Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
  3. Subjects with CD4+ T lymphocyte count \< 200 cells/μL;
  4. 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;
  5. 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;
  6. Received live or attenuated vaccination within 28 days prior to the first administration;
  7. Participated in other clinical trials within 28 days prior to the first administration;
  8. Concomitant with other serious diseases;
  9. 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);
  10. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62 ;
  11. Breastfeeding or pregnant women;
  12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
  13. Other conditions unsuitable for participation in this study determined by the Investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    MIL62(Part A and B)

    Drug: MIL62

  • Placebo comparator
    Placebo (Part A and B)

    Drug: placebo

Interventions

  • DrugMIL62

    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.

  • Drugplacebo

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: at Week 12

Secondary outcomes

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

    Time frame: at Week 52

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

    Time frame: at Week 24

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: up to 76 weeks after randomization

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

    Time frame: 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

    Time frame: up to 76 weeks after randomization

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

    Maximum concentration(Cmax) of the drug after administration

    Time frame: 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

    Time frame: 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

    Time frame: up to 76 weeks after randomization

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05796206
Lead sponsor
Beijing Mabworks Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
May 26, 2023
Primary completion
Feb 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Dec 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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