This clinical trial is focused on studying the effects of a treatment for Primary 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 dry eyes. The treatment being tested is called Efgartigimod, which is administered as a solution for injection using a pre-filled syringe. This study will compare the effects of Efgartigimod with a placebo to understand its impact on the disease.

The purpose of the study is to evaluate how effective and safe Efgartigimod is for patients with Primary Sjögren’s Syndrome. Participants in the study will receive either Efgartigimod or a placebo through subcutaneous injections, which means the injection is given under the skin. The study will follow participants over a period to observe changes in their condition, particularly looking at the activity of the disease and any improvements in symptoms.

Throughout the study, researchers will monitor participants to assess the treatment’s impact on disease activity and overall safety. The study aims to provide valuable information on whether Efgartigimod can help manage symptoms and improve the quality of life for those living with Primary Sjögren’s Syndrome. The trial includes an open-label extension, meaning that after the initial phase, all participants may have the opportunity to receive Efgartigimod, allowing further observation of its long-term effects.