You may be eligible to participate in a Phase 3 clinical trial for cenerimod, a new oral treatment being studied for its potential to reduce disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE). This study, known as
OPUS-1, is a randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy, safety, and tolerability of cenerimod on top of background SLE therapy.

• About Cenerimod: Cenerimod is an investigational drug that acts as a selective S1P1​receptor modulator. Its mechanism of action blocks the egress of lymphocytes (T and B cells) from lymphoid organs, thereby reducing circulating lymphocytes that contribute to inflammation in SLE.
  
• Who can participate: The study is seeking approximately 420 adults aged 18 to 75 who have been diagnosed with moderate-to-severe SLE for at least six months. You must also be currently on a stable dose of a background SLE medication.
  
• Study Design: Participants will be randomly assigned in a 1:1 ratio to receive either 4 mg of cenerimod or a placebo once daily for 12 months.
  
• Key Assessments: The trial will evaluate the drug's effectiveness using primary and secondary endpoints. The primary endpoint is the response on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12, and a key secondary endpoint is the response on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Month 12. Safety and tolerability will also be closely monitored through various assessments, including adverse event reporting, changes in vital signs, ECGs, and laboratory variables .
  
• Exclusion Criteria: Important exclusion criteria include having active, severe SLE-driven renal or central nervous system lupus, a history of certain cardiac conditions like Mobitz type II or third-degree AV block, or a myocardial infarction within the last six months . Additionally, a history of certain malignancies or organ transplantation are exclusionary.
  

Your participation could provide crucial data to support the development of a new treatment option for SLE. If you are interested in learning more, please contact us.