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A Long-Term Extension Study of IMVT-1402 in Adult Patients With Graves' Disease

This long-term extension study is evaluating the safety and effectiveness of IMVT-1402 in adults with Graves’ disease who have completed a previous IMVT-1402 clinical trial. Graves’ disease is an autoimmune condition that causes the thyroid gland to become overactive. IMVT-1402 is an investigational medicine designed to reduce harmful antibodies that contribute to the disease. The study will assess whether continued treatment with IMVT-1402 can help participants maintain normal thyroid hormone levels, reduce or stop the use of antithyroid medications, and achieve sustained control of their disease. Only eligible participants from previous IMVT-1402 studies may enrol in this trial.

What you need to know

Who can take part?

You may be able to take part if you:
•    Have completed one of the previous IMVT-1402 Graves' disease studies and meet the study entry requirements.
•    Are willing to attend study visits and follow study instructions.
•    Agree not to take part in another clinical trial during this study.
•    Are willing and able to receive the study treatment if assigned to the treatment group.
•    Are not pregnant or breastfeeding and are willing to use effective birth control during the study if applicable.

You cannot take part if you have a medical condition, study history, or other circumstance that, in the opinion of the study doctor, makes participation unsuitable or unsafe.

What is involved for me?

If you take part in this study, you will:
•    Join a long-term follow-up study after completing a previous IMVT-1402 study.
•    Be placed into a study group based on your thyroid condition at the end of the previous study.
•    Either receive IMVT-1402 as a weekly injection for up to 52 weeks or be monitored without study treatment.
•    Attend regular study visits for up to 1–2 years.
•    Have blood tests to check your thyroid function and overall health.
•    Have your thyroid medications reviewed and adjusted if needed.
•    Have regular health checks, including measurements such as blood pressure and heart rate.
•    Be monitored for side effects and any changes in your health.
•    Provide blood samples to assess your response to the study treatment.
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