A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' disease is an autoimmune condition where the body's defence system mistakenly causes the thyroid gland to produce too much hormone. While standard antithyroid tablets help many people, they do not work well enough for everyone. This Phase 2 clinical trial is testing an experimental medicine called IMVT-1402. The aim is to find out if it is safe, well-tolerated, and effective at calming an overactive thyroid in adults whose condition is not fully controlled by usual treatments. Participants will be randomly chosen to receive either IMVT-1402 or a dummy drug (placebo). Neither you nor your study doctor will know which one you receive until the trial ends. Doctors will monitor everyone closely throughout the study to check hormone levels and general health.
במבט חטוף
על מה המחקר הזה?
Graves' disease is an autoimmune condition that affects the thyroid, a small butterfly-shaped gland in your neck. Normally, the thyroid produces hormones that control your body's energy and metabolism. In Graves' disease, your immune system mistakenly makes antibodies that tell the thyroid to produce far too much hormone. This can cause symptoms such as a racing heart, trembling hands, weight loss, and feeling anxious or tired.
Doctors usually prescribe antithyroid tablets to slow down hormone production. However, some people continue to have an overactive thyroid despite taking these daily medications. When medicines fail, current options include radioactive iodine treatment or surgery to remove the thyroid gland, but these can have permanent effects. This study is exploring a new medicine called IMVT-1402 to see if it can offer another way to help.
IMVT-1402 is designed to reduce the levels of harmful antibodies in the blood, which researchers hope will help the thyroid return to normal. Because this is a clinical trial, it is set up to test both how well the medicine works and whether it causes any unwanted side effects.
To ensure fair results, this is a 'double-blind, placebo-controlled' study. This means some participants will receive the active study drug, while others receive an inactive dummy medicine called a placebo. A computer decides who gets which treatment by chance, and neither you nor your study team will know which group you are in during the trial.
נקודות עיקריות
- Tests a new medicine (IMVT-1402) for adults with Graves' disease.
- Aimed at people whose thyroid remains overactive despite standard tablets.
- Participants will receive either the study medicine or an inactive placebo.
- People who have had their thyroid removed or had successful radioactive iodine therapy cannot join.
- Taking part is completely voluntary and you can leave at any time.
מי עשוי להיות זכאי?
This trial is open to adults aged between 18 and 75 who have been diagnosed with Graves' disease. To be considered, your thyroid must still be overactive even though you are already taking standard antithyroid tablets. You also need to be able to attend regular clinic visits and follow the study instructions.
You cannot take part if you have already had your thyroid gland removed through surgery, or if you have previously had radioactive iodine therapy that successfully treated your condition. These treatments permanently change how the thyroid works, which means the study medicine cannot be tested fairly.
People with moderate or severe active thyroid eye disease (a condition linked to Graves' that causes swelling or bulging of the eyes) cannot join if they are likely to need urgent treatment or eye surgery during the trial. You may also be unable to take part if you have another significant autoimmune condition that requires treatment that could put your health at risk.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- I am an adult aged between 18 and 75 years old.
- I have been diagnosed with Graves' disease.
- My thyroid is still overactive even though I take standard thyroid tablets.
- I have not had surgery to remove my thyroid gland.
- I have not had successful radioactive iodine treatment in the past.
- I do not have severe, active thyroid eye disease needing urgent surgery.
מה כרוך בהשתתפות?
Taking part in this study involves regular visits to a hospital or specialist research clinic. During these visits, doctors and nurses will closely monitor your general health. You will have regular checks such as blood tests to measure your thyroid hormone levels, blood pressure readings, and heart checks (ECGs). You will be given either the study medicine (IMVT-1402) or a dummy treatment (placebo). You will also be asked about how you are feeling and any symptoms or changes you notice. The study team will explain the exact schedule of clinic visits and how long you will need to take part before you decide to sign up.
סיכונים ותועלות פוטנציאליים
Locations (163)
- Site Number - 1015מיקוד מאומתטוסון, ארצות הברית· גיוס
- Site Number -1014מיקוד מאומתConcord, United States· גיוס
- Site Number - 1013מיקוד מאומתאורורה, ארצות הברית· גיוס
- Site Number - 1024מיקוד מאומתדוראל, ארצות הברית· גיוס
- Site Number - 1008מיקוד מאומתהיאליה, ארצות הברית· גיוס
- Site Number - 1000מיקוד מאומתמיאמי, ארצות הברית· גיוס
- Site Number - 1020מיקוד מאומתקולומבוס, ארצות הברית· גיוס
- Site Number - 1022מיקוד מאומתTopeka, United States· גיוס
- Site Number - 1030מיקוד מאומתלואיוויל, ארצות הברית· גיוס
- Site Number - 1033מיקוד מאומתJefferson City, United States· גיוס
- Site Number - 1004מיקוד מאומתקנזס סיטי, ארצות הברית· גיוס
- Site Number - 1019מיקוד מאומתסנט לואיס, ארצות הברית· גיוס
שאלות נפוצות
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. Researchers use it to compare results fairly and see if the new medicine really makes a difference.
Will I have to pay to take part?
No. The study medication, clinic visits, and all trial-related tests are provided free of charge. Travel expenses to and from the clinic are usually reimbursed.
Can I carry on taking my normal medicines?
The study doctor will review all your current medicines to check which ones you can safely continue taking alongside the study treatment.
What happens if I change my mind?
You can leave the study at any point. Your decision will never affect your relationship with your healthcare team or the standard care you receive.
כיצד ניתן ללמוד רפואה?
The research team will explain the exact method, such as an injection or infusion, and how often it needs to be given before you agree to take part.
כיצד לגלות עוד
Central Study Contact
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
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