This clinical trial is focused on studying a disease called Systemic Lupus Erythematosus (SLE), which is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues. The study is testing a treatment called ianalumab, also known by its code name VAY736. This treatment is given as a solution for injection using a pre-filled syringe. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of ianalumab when used alongside standard treatments for SLE.
Participants in the study will receive either ianalumab or a placebo, which is a substance with no active medication. The study will last for about 60 weeks, during which participants will receive monthly injections. The goal is to see if ianalumab can help improve the condition of patients with SLE by achieving a specific response known as the Systemic Lupus Erythematosus Responder Index (SRI-4) by the end of the study period.
Throughout the study, researchers will monitor participants for any changes in their condition, including the occurrence of flare-ups, which are periods when symptoms worsen. They will also track the use of corticosteroids, a type of medication often used to manage SLE symptoms, to see if ianalumab can help reduce the need for these drugs. The study will also assess the overall health and well-being of participants, including any side effects they may experience. The information gathered will help determine if ianalumab is a beneficial addition to the current standard of care for people with SLE.



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