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

This research study is looking at a new medicine called IMVT-1402. It's for adults who have Graves' disease, a condition where your immune system attacks your thyroid gland, making it overactive. Even though these individuals are taking medicine for their Graves' disease, their thyroid is still working too hard. The main goal of this study is to check how well IMVT-1402 works compared to a dummy medicine (placebo). We'll be looking at your thyroid hormone levels and how much of your usual thyroid medicine you need after 26 weeks. We're also checking that the new medicine is safe and that people can take it without too many problems. This is an important step in developing new treatments for Graves' disease.

Överblick

Status
Rekrytering
Fas
FAS2
Sponsor
Immunovant Sciences GmbH
Inskrivningsmål
240
Starta
17 dec 2024
Beräknad slutförande
01 jun 2028
Graves' Disease

Vad handlar denna studie om?

This study is investigating a new medication called IMVT-1402 for adults with Graves' disease. Graves' disease is an autoimmune condition where your body's immune system mistakenly attacks your thyroid gland, causing it to produce too many thyroid hormones. This can lead to symptoms like anxiety, weight loss, and a fast heartbeat. While there are existing treatments, some people still have an overactive thyroid despite taking their current medication.

The main aim of this study is to find out if IMVT-1402 can help bring thyroid hormone levels back to normal in these individuals. We will compare its effects to a 'placebo' – which looks like the study drug but contains no active medicine – to understand how effective IMVT-1402 truly is. We also want to make sure the medicine is safe and that people can take it without uncomfortable side effects.

Understanding how well this new treatment works and if it's safe is a crucial step. If successful, IMVT-1402 could offer another option for managing Graves' disease, potentially helping people whose current treatments aren't fully controlling their condition.

Viktiga punkter

  • This study is testing a new medicine (IMVT-1402) for Graves' disease.
  • It's for adults whose thyroid is still overactive despite current treatment.
  • The study compares the new medicine to a dummy pill (placebo).
  • It checks if IMVT-1402 is effective, safe, and well-tolerated.
  • Participation involves regular clinic visits for tests and monitoring.

Vem kan vara berättigad?

To join this study, you need to be an adult, at least 18 years old. You must have Graves' disease and your thyroid must still be overactive, even though you are already taking medication for it. You also need to be able to understand what the study involves and agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if you've already had your thyroid treated with radioactive iodine or had surgery to remove it, this study isn't for you. Also, if you have other serious autoimmune conditions that need treatment, or a severe form of thyroid eye disease that needs immediate surgery, you wouldn't be able to participate. The study is designed to make sure it's safe for everyone involved.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är du 18 år eller äldre?
  2. Do you have Graves' disease?
  3. Is your thyroid still overactive even with your current medicine?
  4. Have you *not* had radioactive iodine treatment or thyroid surgery in the past for Graves'?
  5. Do you *not* have other serious autoimmune diseases needing treatment?
  6. Kan du förstå studieinformationen och samtycka till att delta?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you decide to take part, you'll be given either the new medicine, IMVT-1402, or a dummy medicine called a placebo. You won't know which one you're getting, and neither will your study doctor, until the very end of the study. You will have regular visits to the clinic where the study team will monitor your health, check your thyroid hormone levels with blood tests, and ask about any side effects you might be experiencing. They will also review your usual thyroid medication dose. The total duration of your participation in the study will involve regular check-ups over several months to carefully track your progress and any changes in your health.

Potentiella risker och fördelar

Taking part in a study like this might offer a potential benefit if the new medicine helps to control your Graves' disease better than your current treatment. However, there's no guarantee it will work for you, and there's a chance you might experience side effects from the new medicine. Because some people will receive a placebo, they might not receive any active treatment from the study. All procedures carry some risks, and the study team will explain these to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (134)

  • Site Number - 1032
    Verifierat postnummer
    Phoenix, USA· Återkallad
  • Site Number - 1036
    Verifierat postnummer
    Phoenix, USA· Rekrytering
  • Site Number - 1061
    Verifierat postnummer
    Huntington Beach, USA· Rekrytering
  • Site Number - 1001
    Verifierat postnummer
    Los Angeles, USA· Rekrytering
  • Site Number - 1047
    Verifierat postnummer
    Los Angeles, USA· Rekrytering
  • Site Number - 1062
    Verifierat postnummer
    Orange, USA· Rekrytering
  • Site Number - 1046
    Verifierat postnummer
    Sacramento, USA· Rekrytering
  • Site Number - 1034
    Verifierat postnummer
    San Francisco, USA· Rekrytering
  • Site Number - 1035
    Verifierat postnummer
    Santa Clarita, USA· Återkallad
  • Site Number - 1005
    Verifierat postnummer
    Torrance, USA· Rekrytering
  • Site Number - 1006
    Verifierat postnummer
    Walnut Creek, USA· Återkallad
  • Site Number - 1013
    Verifierat postnummer
    Englewood, USA· Rekrytering

Vanliga frågor

What is Graves' disease?

Graves' disease is an immune condition that makes your thyroid gland produce too much hormone, leading to symptoms like a fast heart rate and weight loss.

Vad är en 'Fas 2'-studie?

Phase 2 studies are an early step in testing new medicines. They check if the medicine works, is safe, and what dose might be best, after initial safety tests.

Vad är en placebo?

A placebo is a dummy medicine that looks exactly like the study drug but doesn't contain any active ingredients. It helps us see if the new medicine really works.

Will I still take my regular thyroid medicine?

Yes, you will continue to take your antithyroid medications during the study, and these doses will be carefully monitored by the study team.

Hur länge varar studien?

The main part of the study involves following your health and thyroid levels for 26 weeks, plus additional follow-up visits.

Hur du får reda på mer

Central Study Contact

clinicaltrials@immunovant.com 18007970414 Officiell rättegångsprotokoll

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