A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Moderately to Severely Active Systemic Lupus Erythematosus

Stage 1: The proportion of patients achieving a response in an SLE Responder Index (SRI-4) at Week 52; Safety and tolerability of telitacicept 160 mg and 240 mg in adult patients with active SLE; PK and PD of telitacicept 160 mg and 240 mg when administered as a subcutaneous injection via prefilled syringes in adult patients with active SLE., Stage 2: The proportion of subjects achieving an SLE Responder Index (SRI-4) at Week 52.

Stage 1: The proportion of adult patients achieving a response in an SLE Responder Index (SRI-4) at Week 24., Stage 2: The proportion of subjects achieving a BILAG-based Combined Lupus Assessment (BICLA) response at week 52, Stage 2: Among subjects who were on an average daily dose of >7.5 mg/day prednisone or equivalent at baseline, the proportion of those subjects achieving a GC dose reduction of ≥25% from baseline to ≤7.5 mg/day prednisone or equivalent by Week 40 and maintaining that dose through Week 52., Stage 2: Time to flare assessed by SFI from baseline through Week 52, Stage 2: The proportion of subjects achieving an SRI-4 response at Week 52, while maintaining an average daily dose of ≤7.5 prednisone or equivalent between Week 40 and Week 52.

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