Lonigutamab for Thyroid Eye Disease

(TED Trial)

This trial tests a new treatment called lonigutamab for individuals with Thyroid Eye Disease (TED). Researchers aim to determine if different doses of lonigutamab can reduce symptoms such as bulging eyes. Participants will receive injections of either lonigutamab or a placebo (a substance with no active treatment). Ideal candidates are those who have recently developed TED symptoms and have noticeable eye bulging (3 mm above normal). This study excludes individuals with certain eye conditions or those who have previously used specific treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial requires that you have not used certain medications recently, like steroids for TED, IGF-1R inhibitors, or other immunosuppressive agents. If you're on these, you might need to stop them before joining, but the protocol doesn't specify about other medications.

Research shows that lonigutamab is being tested for safety in treating thyroid eye disease. Previous studies found that patients generally tolerate this treatment well. Reported side effects are mostly mild to moderate, such as injection site reactions or mild flu-like symptoms. Serious side effects have not commonly appeared in the research.

Lonigutamab is unique because it targets the underlying cause of thyroid eye disease, potentially offering more precise treatment than traditional options like corticosteroids or radiation therapy. Unlike these standard treatments, which often address symptoms, lonigutamab is designed to be administered via subcutaneous injections, offering a potentially more convenient and patient-friendly delivery method. Researchers are excited about its ability to work on a molecular level, which could lead to better outcomes with fewer side effects.

Research has shown that lonigutamab, a specially designed antibody, may help treat thyroid eye disease (TED). Early findings suggest it can greatly reduce eye inflammation and other symptoms of TED. In past studies, patients who received lonigutamab experienced significant improvements in their eye condition compared to before treatment. The evidence indicates that this treatment effectively targets and blocks IGF-1R, which plays a key role in TED. In this trial, participants will receive different doses of lonigutamab to evaluate its effectiveness. Overall, early results are promising for lonigutamab's ability to improve symptoms for those with TED.³⁶⁷⁸⁹