Overview
This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Eligibility
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 ;
- 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.
Exclusion Criteria:
- Unsufficient organ function;
- Have received treatment with B cell targeted therapy within 9 months prior to the first administration;
- Subjects with CD4+ T lymphocyte count < 200 cells/μL;
- Receipt of any of the following prior to the first administration: Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
- Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the first administration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2 months 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；
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
- 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.