A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

To join this study, you need to be at least 18 years old. You must have a diagnosis of Primary Sjögren's Syndrome that was confirmed using specific medical criteria, and your symptoms should be considered moderate to severe. Importantly, your blood tests must show that you are positive for a specific marker called Anti-Ro/SS-A, which is common in Sjögren's. You also need to have some natural saliva production, even if it's very little.

There are also reasons why someone might not be able to join. For example, if your Sjögren's is linked to another autoimmune condition like rheumatoid arthritis or lupus, you wouldn't be eligible for this specific study. Also, if you have active fibromyalgia that isn't under control, or if you've recently received certain strong medications (like cyclophosphamide or specific antibody treatments) within the past few months, you might not be able to take part.

If you decide to take part in this study, you'll be involved for about two years. During this time, you'll have regular visits to the clinic where the study team will monitor your health and how you're responding to treatment. You'll receive either the new study medicine (efgartigimod) or a placebo (a dummy treatment) through injections under the skin. Initially, it's a 'double-blind' period, meaning neither you nor your doctor will know which treatment you're receiving. This helps make the study results as fair as possible. After this first stage, you'll be offered the active study medicine. The study team will conduct various assessments, including physical exams, blood tests, and questionnaires, to track your symptoms and general well-being. You'll also receive ongoing medical care and support from the study team throughout your participation.