OPUS-1 - Oral S1P1 Receptor ModUlation in SLE: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy

Moderate to severe systemic lupus erythematosus

Response on Systemic Lupus Erythematosus Responder Index (SRI-4) at Month 12 compared to baseline.

Response on British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline., Time to first confirmation of a 4-month sustained mSLEDAI-2K response, defined as a reduction of at least 4 points from baseline., Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers), defined as: • No increase in the overall mSLEDAI-2K score excluding mucocutaneous manifestations, and • Remission (score of zero) from baseline in the mSLEDAI-2K score of mucocutaneous manifestations.

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Bulgaria, France, Greece, Poland, Romania