This clinical trial is focused on studying the effects of a treatment for Sjögren’s syndrome, a condition where the body’s immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and eyes. The treatment being tested is called ianalumab, also known by its code name VAY736. It is administered as a solution for injection using a pre-filled syringe. The study also includes a comparison with a placebo, which is a substance with no active medication, to evaluate the effectiveness of ianalumab.

The purpose of the study is to assess how well ianalumab works and how safe it is for patients with active Sjögren’s syndrome. Participants in the study will be randomly assigned to one of three groups: one receiving ianalumab, one receiving a placebo, and another group receiving a standard treatment known as glucocorticoids, which are a type of steroid medication taken orally. The study will last for a total of 52 weeks, during which participants will receive regular injections and have their health monitored closely by the research team.

Throughout the study, the main focus will be on changes in the participants’ health, particularly looking at the ESSDAI score, which is a measure used to assess disease activity in Sjögren’s syndrome. The study aims to demonstrate whether ianalumab is more effective than the placebo in improving this score over the course of the study. Participants will also be monitored for any side effects or changes in their condition to ensure the treatment’s safety and tolerability.