Upon joining the study, you will be randomly assigned to receive either the study medication, nipocalimab, or a placebo. A placebo is a substance that looks like the study medication but does not contain any active ingredients.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not influenced by expectations.

You will receive the treatment as a solution for injection under the skin, known as subcutaneous use. The exact dosage and frequency will be determined by the study protocol and communicated to you by the study team.

The treatment period will last for a specified duration, during which you will be monitored regularly to assess the effects of the treatment on your condition.

Throughout the study, you will have regular visits with the study team. These visits will include physical examinations, discussions about any changes in your health, and possibly additional tests to monitor your condition.

Your progress will be evaluated using a specific score called the Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI). This score helps measure the activity of your Sjogren’s Disease.

At the end of the treatment period, which is expected to be around 48 weeks, your condition will be assessed to determine any changes from the start of the study.

The primary goal is to observe any change in your ClinESSDAI score, which will help evaluate the effectiveness of the treatment.

After completing the treatment phase, there may be additional follow-up visits to monitor your health and gather further information about the long-term effects of the treatment.

These follow-up visits are important to ensure your well-being and to collect comprehensive data for the study.