Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
brief summary
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
detailed description
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).
official title
A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)