The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
This extension study will last up to 7 years and includes the following three treatment periods:
* a 3-year double-blind, randomized, placebo-controlled treatment period, evaluating the safety and efficacy of ianalumab or placebo (Period 1);
* followed by a 2-year treatment period evaluating safety and efficacy of treatment withdrawal and open-label ianalumab administered s.c. monthly.
* and an up to 2-year open-label, safety monitoring period (Period 3).