This study focuses on people with Graves’ Disease, which is an autoimmune condition that causes the thyroid gland to produce too much thyroid hormone. The research evaluates a new medication called IMVT-1402, which is given as an injection under the skin.
The purpose of this research is to determine how well IMVT-1402 works compared to placebo in treating adults with Graves’ Disease. The study examines the medication’s effects on thyroid hormone levels and the need for standard thyroid medications over a 26-week period.
During the study, participants will receive either IMVT-1402 injections or placebo. The medication will be given as a subcutaneous injection, which means it is administered under the skin. The maximum daily dose of the study medication can be up to 600 milligrams. The study will monitor how the treatment affects thyroid hormone levels and overall thyroid function throughout the treatment period.
1Initial visit and trial start
You will be diagnosed with Graves’ Disease and currently receiving ATD (Anti-Thyroid Drug) treatment
Your thyroid hormone levels will be checked to confirm they are above normal despite ATD treatment
You must be 18 years or older to participate
2Treatment assignment
You will be randomly assigned to receive either IMVT-1402 or a placebo
The treatment will be given as an injection under the skin (subcutaneous injection)
Neither you nor your doctor will know which treatment you are receiving
3Early monitoring phase
Your thyroid hormone levels (T3, T4, and TSH) will be checked at week 2
Another check of thyroid hormone levels will be performed at week 4
These tests will determine how your body is responding to the treatment
4Main treatment period
The treatment will continue for a total of 26 weeks
Regular monitoring of your thyroid function will occur throughout this period
Your ATD dose may be adjusted based on your response to treatment
5Final evaluation
At week 26, final assessments will be performed to check:
Whether your thyroid hormone levels have returned to normal range
If you are able to stop taking ATD medication
The presence of thyroid antibodies in your blood
Who Can Join the Study?
Must be able to understand the trial requirements and agree to participate by providing written informed consent
Must be 18 years of age or older
Must have a diagnosis of Graves’ Disease with symptoms of overactive thyroid (hyperthyroid) despite being on anti-thyroid drug treatment (medications that reduce thyroid hormone production)
Must be willing and able to follow all study procedures and requirements
Can be either male or female
Who Cannot Join the Study?
Age below 18 years or above 75 years
Pregnant or breastfeeding women
History of thyroid cancer or suspected thyroid cancer
Severe liver problems (as indicated by liver function tests more than 3 times the normal range)
Severe kidney disease (requiring dialysis or with severely reduced kidney function)
Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
Major surgery within 3 months before the start of the study
Current participation in other clinical trials
History of allergic reactions to similar medications
Significant heart problems, including heart failure or recent heart attack
Untreated or unstable mental health conditions
Active infections that require treatment
Use of medications that could interfere with thyroid function tests
Alcohol or drug abuse within the past year
Any condition that, in the opinion of the study doctor, would make participation unsafe
IMVT-1402 is an investigational medication being studied for the treatment of Graves’ Disease, an autoimmune disorder that affects the thyroid gland. This medication is designed to help regulate thyroid hormone levels in adult patients. It works by targeting the immune system’s response that causes the thyroid to produce excess hormones in Graves’ Disease.
Anti-thyroid drugs (ATDs) are standard medications used to treat Graves’ Disease. These medications help reduce the production of thyroid hormones. In this study, they are used alongside the investigational treatment to monitor how well IMVT-1402 works in helping patients potentially reduce their need for standard thyroid medications.
Graves’ Disease – An autoimmune disorder that affects the thyroid gland, causing it to produce excessive amounts of thyroid hormones. The condition typically develops gradually and leads to an overactive thyroid state known as hyperthyroidism. The immune system creates antibodies that stimulate the thyroid gland to grow and produce more thyroid hormones than the body needs. Common manifestations include enlargement of the thyroid gland, changes in energy levels, and alterations in metabolism. The condition can also affect the eyes, causing them to become irritated or protruding.
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