This clinical trial focuses on evaluating a new treatment for Sjögren’s Disease, an autoimmune condition that primarily affects the body’s moisture-producing glands, causing symptoms like dry eyes and dry mouth. The study will test a medication called sibeprenlimab (also known as VIS649) given as an injection under the skin, compared to a placebo, in addition to patients’ regular treatments.

The purpose of this research is to determine how well sibeprenlimab works in treating Sjögren’s Disease symptoms compared to placebo after 28 weeks of treatment. During the study, participants will receive either sibeprenlimab or placebo through subcutaneous injections. The maximum single dose will be 400 mg, with treatment continuing for up to 52 weeks.

Throughout the study, researchers will monitor various aspects of the disease, including changes in tear and saliva production, fatigue levels, and overall disease activity. The study will also track how well participants tolerate the medication by monitoring their health and any side effects that may occur. Participants may continue taking certain background medications they were already using, such as hydroxychloroquine, methotrexate, leflunomide, or azathioprine, as long as their doses have been stable.