A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
• Age 12-70 years at screening.
• Has a diagnosis of SLE for at least 6 months prior to the screening visit.
• Meets the 2019 EULAR/ACR Classification criteria for SLE.
• Moderately to severely active SLE definined by the following:
‣ SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
⁃ BILAG organ system scores of at least 1A or 2B at screening.
• Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
• At least one positive serologic parameter within the screening period.
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.