This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called ianalumab for patients with Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease where the body’s immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and dry eyes. The study involves the use of ianalumab, which is administered as a solution for injection. Participants in the study may also receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.
The purpose of the study is to assess how well ianalumab works over a long period and to monitor any side effects that may occur. Participants will be randomly assigned to receive either ianalumab or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will continue for several years, allowing researchers to gather comprehensive data on the treatment’s safety and effectiveness.
Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. Blood samples will be taken to measure the levels of ianalumab in the body and to check the number of B-cells, which are a type of immune cell. The study aims to provide valuable information on the potential benefits of ianalumab for people living with Sjögren’s syndrome, contributing to better treatment options in the future.



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