A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Eligibility Criteria

• 1. Age 12-70 years at screening.
• 2. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
• 3. Meets the 2019 EULAR/ACR Classification criteria for SLE.
• 4. Moderately to severely active SLE definined by the following:
• 1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
• 2. BILAG organ system scores of at least 1A or 2B at screening.
• 5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
• 6. At least one positive serologic parameter within the screening period.
• 7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
• 1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
• 2. Active or unstable neuropsychiatric SLE.
• 3. Autoimmune or rheumatic disease other than SLE.
• 4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
• 5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.