Ingenio San Miguel

Researchers are studying the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus who test positive for anti-nuclear antibodies. This extension study involves participants who previously completed treatment in one of two core SIRIUS-SLE studies. The aim is to monitor how well ianalumab is tolerated over an extended period compared to a placebo. The study compares monthly or quarterly subcutaneous injections of ianalumab to monthly placebo injections. Participants receive these treatments after completing the initial core studies (CVAY736F12301 or CVAY736F12302). This extension phase focuses on continued monitoring of these treatments over a long time frame. Participants will be observed for treatment-emergent adverse events and serious adverse events for up to approximately 91 months. Assessments include monitoring safety and tolerability throughout the study period. The total participation duration depends on individual study completion, with ongoing evaluation to ensure participant well-being during this extended follow-up.