This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .
Voluntarily participate in the clinical study and sign a written informed consent form.
Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease.
SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points.
Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity.
Previous use of CD38 or monoclonal antibodies targeting CD38.
Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol.
Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis.
Laboratory abnormalities.
Parallel
SG301 SC Injection
DrugOne injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.
SG301 SC Injection
DrugOne injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered, among which 2 injections are placebos
SG301 SC placebo
DrugOne injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points; * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline; * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline;
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