Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)

Inclusion criteria

• Males or females aged 18 to 65 years.
• Voluntarily signed the informed consent form (ICF).
• Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
• Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
• Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
• ≥1British Isles Lupus Assessment Group-2004 (BILAG-2004) organ system rated as A or ≥ 2 organ system rated as B, and Physician's Global Assessment(PGA) score ≥1.0 during screening.
• Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.

Exclusion criteria

• Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
• Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
• There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
• History of clinically significant diseases.