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A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

This study is for adults who have already taken part in a previous clinical trial for Graves' Disease, where they received a medicine called IMVT-1402. It's a 'long-term extension study,' meaning it continues to follow these participants to see how the medicine works over a longer time. The main goals are to find out if IMVT-1402 continues to be effective in managing Graves' Disease and if it remains safe when used for an extended period. Participants will be grouped based on their Graves' Disease status when they finished the earlier study. This helps researchers gather more complete information about the potential benefits and any side effects of the treatment.

Auf einen Blick

Status
Einschreibung auf Einladung
Phase
PHASE2
Sponsor
Immunovant Sciences GmbH
Einschreibeziel
372
Starten
26. Jan 2026
Geschätzte Fertigstellung
01 Mar 2030
Morbus Basedow

Worum geht es in dieser Studie?

Graves' Disease is a condition where your immune system mistakenly attacks your thyroid gland, making it produce too many hormones. This can cause various symptoms like a fast heartbeat, weight loss, and anxiety. Doctors are always looking for new and better ways to help people manage this condition.

This study is about a medicine called IMVT-1402, which is being tested as a potential treatment for Graves' Disease. This particular study is called a 'long-term extension study.' This means it's not starting with new patients, but rather continuing to follow people who have already been taking part in an earlier study for IMVT-1402. The main goal is to understand how well the medicine works and if it is safe over a longer period of time.

By continuing to observe these patients, researchers can gather important information that can't be learned in shorter studies. This includes seeing if the medicine keeps working effectively, if there are any long-term side effects, and how it impacts people's health over months or even years. This kind of information is vital to help doctors and patients make informed decisions about future treatments for Graves' Disease.

Wichtige Erkenntnisse

  • This study is for adults already in an IMVT-1402 trial for Graves' Disease.
  • It's a longer-term follow-up to check safety and effectiveness.
  • Participants will continue receiving IMVT-1402 medicine.
  • Regular health checks and tests will be part of the study.
  • The aim is to gather more complete information about the treatment.
  • Die Teilnahme ist freiwillig, und Sie können jederzeit zurücktreten.

Wer könnte berechtigt sein?

This study is specifically for adults who have already been taking part in one of two previous clinical trials for Graves' Disease. These earlier studies were called IMVT-1402-2502 or IMVT-1402-2503.

To be considered for this long-term study, you must have successfully completed your previous IMVT-1402 study. This means you didn't stop taking the study medicine early and didn't have any serious problems that caused you to leave the study before it finished. Your study doctor will know if you meet these specific requirements.

There might be other detailed reasons why someone could or couldn't join, which your study team would discuss with you. These are usually in the study plan, known as the 'protocol.'

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Are you an adult (18 years or older)?
  2. Have you taken part in Study IMVT-1402-2502 or Study IMVT-1402-2503 for Graves' Disease?
  3. Did you complete your previous study without stopping the medicine early?
  4. Were there no reasons that caused you to leave your previous study?
  5. Are you prepared for ongoing medical check-ups?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you join this study, it means you'll continue to receive the IMVT-1402 medicine you were taking in the previous trial. You'll be placed into one of three groups based on how your Graves' Disease was doing at the end of your last study. This helps the researchers learn more specifically about the medicine's effects in different situations.

You will have regular appointments at the clinic for check-ups. During these visits, the study team will monitor your health, ask about any symptoms or side effects you might be experiencing, and carry out various tests. These tests might include blood samples to check your thyroid hormone levels and other general health markers. The total length of your participation will depend on the study plan, but it's designed to be a longer-term follow-up.

Potenzielle Risiken und Vorteile

Taking part in any clinical study, including this one, has potential benefits and risks. A possible benefit is that you would continue to receive a medicine that might help manage your Graves' Disease, and you would be closely monitored by a medical team. However, the medicine might not work for everyone, or it might cause side effects, some of which could be unexpected or serious. All known risks will be thoroughly explained to you by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (131)

  • Site Number - 1561
    Verifizierte Postleitzahl
    Phoenix, Vereinigte Staaten
  • Site Number - 1519
    Verifizierte Postleitzahl
    Phoenix, Vereinigte Staaten
  • Site Number - 1530
    Verifizierte Postleitzahl
    Tucson, Vereinigte Staaten
  • Site Number - 1510
    Verifizierte Postleitzahl
    Concord, Vereinigte Staaten
  • Site Number - 1587
    Verifizierte Postleitzahl
    Huntington Beach, Vereinigte Staaten
  • Site Number - 1554
    Verifizierte Postleitzahl
    Los Angeles, Vereinigte Staaten
  • Site Number - 1588
    Verifizierte Postleitzahl
    Orange, Vereinigte Staaten
  • Site Number - 1559
    Verifizierte Postleitzahl
    San Francisco, Vereinigte Staaten
  • Site Number - 1558
    Verifizierte Postleitzahl
    Santa Clarita, United States
  • Site Number - 1552
    Verifizierte Postleitzahl
    Torrance, Vereinigte Staaten
  • Site Number - 1533
    Verifizierte Postleitzahl
    Aurora, Vereinigte Staaten
  • Site Number -1514
    Verifizierte Postleitzahl
    Englewood, United States

Häufige Fragen

Was ist das Hauptziel dieser Studie?

The main goal is to find out how well the medicine IMVT-1402 works and if it's safe for people with Graves' Disease over a longer period of time.

Wer kann an dieser Studie teilnehmen?

This study is only for adults who have already completed a specific previous study (IMVT-1402-2502 or IMVT-1402-2503) for Graves' Disease.

What is Graves' Disease?

Graves' Disease is a condition where your immune system causes your thyroid gland to make too many hormones, leading to various symptoms.

Will I get a new medicine in this study?

No, you will continue to receive the IMVT-1402 medicine you were taking in the previous study.

Kann ich die Studie verlassen, wenn ich meine Meinung ändere?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

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