A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SG301 SC Injection in Patients With Systemic Lupus Erythematosus
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.
• Body weight ≥ 35 kg.
• Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose.
• Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose.