A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

To be considered for this study, you must have already completed one of the earlier NEPTUNUS studies (NEPTUNUS-1 or NEPTUNUS-2) all the way through to Week 48. Your study doctor also needs to believe that continuing to take ianalumab would be helpful for your Sjögren's Syndrome.

There are also some reasons why you might not be able to join. For example, if you are currently using treatments that were not allowed in the original NEPTUNUS studies. You also cannot participate if you plan to get certain types of vaccinations during the study.

Pregnant or breastfeeding women cannot join this study. If you are a woman who could become pregnant, you would need to use highly effective birth control methods throughout the study and for 6 months after your last dose. Men and women aged between 18 and 75 years old can be considered.

If you decide to take part, there's no initial screening period. You will be invited to join around Week 48 of your original NEPTUNUS study. Initially, for a period, you might receive ianalumab once a month or every three months through an injection, similar to how you received treatment in the previous study. If you were on a dummy treatment (placebo) before, you would be randomly assigned to receive ianalumab either monthly or every three months.

During this initial period, some participants receiving injections every three months will also receive monthly dummy injections to ensure everyone remains 'blind' to who is getting the active medicine. Later on, everyone will switch to open-label treatment, meaning everyone will know they are receiving ianalumab 300 mg monthly. This treatment period, including both phases, will last for about 6 years. After you finish the treatment, you will be monitored for at least 20 weeks, and potentially longer, to keep an eye on your health.