A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus
In brief
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Key facts
- Study ID
- NCT07405970
- Run by
- Beijing Mabworks Biotech Co., Ltd.
- People needed
- 316
- Starts
- 2026-04-10
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- 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.
Where it is running
- Peking University People's Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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