A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus

Inclusion criteria

• 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.

Exclusion criteria

• 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.