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RecruitingPHASE2INTERVENTIONAL

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

This research study is for adults who have Graves' disease, a condition where the immune system attacks the thyroid gland, making it overactive. Even with their current medication, their thyroid might still be working too hard. The study is testing a new medicine called IMVT-1402 to see if it's safe and effective in controlling the overactive thyroid. Some participants will receive IMVT-1402, and others will receive a dummy medicine (placebo), without anyone knowing who gets what until the end. This is a common way to properly test new treatments. The goal is to find better ways to help people living with Graves' disease.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Immunovant Sciences GmbH
Enrolment target
210
Start
19 Jun 2025
Estimated completion
01 May 2027

What is this study about?

This study is all about finding new and better ways to treat Graves' disease. Graves' disease is a condition where your body's immune system accidentally attacks your thyroid gland, making it produce too many thyroid hormones. This can lead to symptoms like anxiety, weight loss, and a fast heartbeat. While there are treatments available, such as antithyroid drugs, some people still struggle to get their thyroid hormone levels under control.

Researchers are investigating a new medicine called IMVT-1402. They want to see if this new treatment can effectively and safely help people with Graves' disease whose thyroid is still overactive even when taking their current medication. By comparing IMVT-1402 with a 'dummy' medicine (placebo), the doctors can understand if the new drug truly makes a difference.

This is a 'Phase 2b' study, which means it builds on earlier testing and involves a larger group of participants. It's a very important step in seeing if IMVT-1402 could become a new option for patients in the future. The results from this study will help us understand if this medicine is both safe and works well for people with Graves' disease.

Key takeaways

  • This study is testing a new medicine (IMVT-1402) for Graves' disease.
  • It's for adults whose thyroid is still overactive even with current medication.
  • The study aims to check if the new medicine is safe and effective.
  • You might receive the new medicine or a dummy medicine (placebo).
  • Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have Graves' disease. You would be considered if your thyroid is still overactive even though you are already taking medication for it. You also need to be able to understand what the study involves and be willing to follow the study plan.

However, some things might mean you can't join. For example, if you've already had a specific type of radiation treatment for your thyroid or have had your thyroid completely removed, you wouldn't be able to take part. Also, if you have other serious autoimmune conditions that need ongoing treatment, or if you have severe eye problems related to Graves' disease that need urgent treatment, this study might not be right for you. The study team will check all these details carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you aged 18 to 75?
  2. Do you have Graves' disease?
  3. Is your thyroid still overactive even though you're taking medication for it?
  4. Have you not had radioactive iodine treatment or surgery to remove your whole thyroid before?
  5. Do you not have severe eye problems from Graves' disease that need urgent treatment?
  6. Are you able to understand and follow the study instructions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be regularly seen by the study team. This will involve visits to the clinic where you'll have various check-ups, blood tests, and other assessments to monitor your health and how the treatment is affecting you. You'll be given either the new study medicine, IMVT-1402, or a dummy medicine called a placebo – you won't know which one you're receiving, and neither will your study doctor. This is standard practice in clinical trials to ensure fair testing.

You'll need to take the study medicine as instructed, and the team will explain exactly how to do this. There will be follow-up appointments over a period to see how you're doing after the main treatment phase. The research team will give you a detailed calendar of appointments and explain everything thoroughly before you agree to participate. The total duration of your participation will be explained to you.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new medicine that could help control your Graves' disease better than your current treatment, and you'll receive careful medical monitoring. However, there are also potential risks; the new medicine might cause side effects, or it might not help your condition. You might also find the visits and tests inconvenient. It's very important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (136)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Site Number - 1015
    Verified postcode
    Tucson, United States· Recruiting
  • Site Number -1014
    Verified postcode
    Concord, United States· Recruiting
  • Site Number - 1013
    Verified postcode
    Aurora, United States· Recruiting
  • Site Number - 1024
    Verified postcode
    Doral, United States· Recruiting
  • Site Number - 1008
    Verified postcode
    Hialeah, United States· Recruiting
  • Site Number - 1000
    Verified postcode
    Miami, United States· Recruiting
  • Site Number - 1020
    Verified postcode
    Columbus, United States· Recruiting
  • Site Number - 1022
    Verified postcode
    Topeka, United States· Recruiting
  • Site Number - 1030
    Verified postcode
    Louisville, United States· Recruiting
  • Site Number - 1033
    Verified postcode
    Jefferson City, United States· Recruiting
  • Site Number - 1004
    Verified postcode
    Kansas City, United States· Recruiting
  • Site Number - 1019
    Verified postcode
    St Louis, United States· Recruiting

Common questions

What is Graves' disease?

Graves' disease is when your body's immune system attacks your thyroid gland, making it produce too much hormone. This is called an 'overactive thyroid'.

What is IMVT-1402?

IMVT-1402 is a new medicine being tested to see if it can help control an overactive thyroid in people with Graves' disease.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctor will know during the study. This helps ensure the results are unbiased and accurate.

Can I continue my regular Graves' disease medication?

The study is for people whose thyroid is still overactive despite current medication, so you might be on your usual treatment. The study team will advise you on all medications.

How to find out more

Central Study Contact

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess the Efficacy, Safety, and Tolerability of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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