JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
Trial Parameters
Brief Summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical Collaboration (SLICC) criteria. 2. Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have been dose stable for \>2 weeks, with the disease remaining active (i.e., prior glucocorticoid + immunosuppressant or glucocorticoid + immunosuppressant + biologics, any of the above medications alone do not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day; 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for corticosteroids. 3. positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening