This study will test a new drug called IMVT-1402 to see if it works and is safe compared to a placebo (a treatment with no medicine) in adults with Graves' Disease. Graves' Disease makes the thyroid gland overactive. We want to see if IMVT-1402 can help people reach normal thyroid hormone levels and possibly stop taking their regular thyroid medicine. The study will compare how well IMVT-1402 works compared with those who get the placebo.
Graves' Disease can cause problems like weight loss, shaking, and eye changes from high thyroid levels. Some people still have symptoms even while taking medicine. The study will test if IMVT-1402 is safe and can bring thyroid levels back to normal without needing long-term thyroid medication. About 210 people from different countries will take part. If you join, you will first go through tests to see if you qualify. This screening period lasts about 5 weeks, and includes blood and urine, heart tests (ECG), physical exams, eye exams, and vital signs. After the screening period, you will start about 26 weeks of treatment. During this time, you will get weekly injections of IMVT-1402 or placebo. A nurse can give injections at your home, or you can be trained to do them yourself. This is a double-blind study. That means neither you nor the study doctor will know who is getting IMVT-1402 or placebo. You will have both clinic and at home check-ins with the study team. You will also have blood and urine tests, heart tests (ECGs), physical exams, eye exams, and vital signs measured. You will answer short health questions and learn how to give injections at home if you prefer. After the 26-week treatment, you will have 4 weeks of follow-up to check your health. The whole study will take about 35 weeks. You may be invited to join a longer follow-up study afterward.
You may be able to join if you are an adult with Graves' Disease and have very low thyroid-stimulating hormone (TSH) and high thyroid antibodies (TRAb greater than 3 times normal) during screening. You must have been taking thyroid medication (like methimazole or PTU) for at least 3 to 6 months, at the same dose. You cannot join if you are pregnant, breastfeeding, or planning to become pregnant during the study. Both men and women must use birth control during the study. You also cannot join if you are in another research study or taking another new study drug.
Protocol Number: 25-1279
Principal Investigator