The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.
BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
Active or unstable neuropsychiatric SLE or lupus nephritis
Autoimmune or rheumatic disease other than SLE
Significant, uncontrolled medical conditions not related to SLE
Active and/or severe viral, bacterial or fungal infection