Ianalumab for Sjögren's Syndrome

(THALASSA Trial)

This trial tests a new treatment called ianalumab, an experimental drug, to determine its effectiveness for people with Sjögren's syndrome. This condition causes the immune system to attack moisture-producing glands, leading to symptoms like dry mouth and eyes. The study aims to assess the treatment's effectiveness and safety when administered as a monthly injection over a year. Participants will receive either the actual treatment or a placebo (a substance with no active drug) to compare results. The trial seeks individuals diagnosed with Sjögren's syndrome who experience significant dryness and are on stable doses of certain medications for the condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

If you are taking hydroxychloroquine (up to 400 mg/day), you can continue it as long as you've been on a stable dose for at least 4 weeks before the trial and maintain it during the study. Prednisone (up to 5 mg/day) is allowed for up to 16 weeks after starting the trial. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Research has shown that ianalumab (VAY736) is generally safe for people with Sjögren's disease. In previous studies, this treatment demonstrated a good safety record, causing few serious side effects. Notably, the side effects were similar to those experienced by people taking a placebo (a substance with no active medication).

Patients tolerated ianalumab well for up to two years, suggesting its safety for long-term use. They reported side effects at rates similar to those who did not receive the actual drug, indicating a positive safety profile.

Unlike the standard treatments for Sjögren's Syndrome, which often focus on managing symptoms with medications like corticosteroids or hydroxychloroquine, Ianalumab (VAY736) targets the immune system more directly. Ianalumab is a monoclonal antibody designed to inhibit B cells, a type of immune cell that can contribute to the autoimmune process in Sjögren's Syndrome. This targeted mechanism of action could potentially address the root cause of the condition rather than just alleviating symptoms, offering a promising new approach for patients. Researchers are excited about Ianalumab because it holds the potential to provide more effective relief with a once-monthly subcutaneous injection, which could be more convenient for patients than some existing therapies.

Research has shown that ianalumab (VAY736), which participants in this trial may receive, may help treat Sjögren's syndrome. Studies have found that patients taking ianalumab experienced a noticeable decrease in symptoms over time. In one study, the treatment proved effective up to week 52, and most patients tolerated it well, experiencing only mild side effects. These results suggest that ianalumab could be a useful option for managing this condition.¹²³⁴⁵