IMVT-1402 for Graves' Disease

Enrolling by invitation at 104 trial locations
CS
Overseen ByCentral Study Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Immunovant Sciences GmbH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of IMVT-1402, an experimental treatment for Graves' Disease (GD), a condition characterized by an overactive thyroid. Participants will join one of three study groups based on their condition at the conclusion of an earlier study. Eligible participants must have completed either of the earlier studies, IMVT-1402-2502 or IMVT-1402-2503. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

Is there any evidence suggesting that IMVT-1402 is likely to be safe for humans?

Research has shown that IMVT-1402 is generally safe for people with Graves' disease. Studies found that most participants experienced only mild or moderate side effects, indicating they were not serious. This suggests that IMVT-1402 is safe for treating Graves' disease. However, discussing potential risks and benefits with a healthcare provider is important before joining a clinical trial.12345

Why do researchers think this study treatment might be promising for Graves' Disease?

Most treatments for Graves' Disease focus on managing symptoms with medications like methimazole, propylthiouracil, or beta-blockers, which mainly reduce thyroid hormone production or control symptoms like rapid heart rate. But IMVT-1402 works differently, targeting and modulating the immune system to address the underlying autoimmune process that causes the disease. Researchers are excited about IMVT-1402 because it could offer a more targeted approach, potentially leading to better long-term outcomes with fewer side effects. This treatment could transform how we manage Graves' Disease, moving beyond symptom management to addressing the root cause.

What evidence suggests that IMVT-1402 might be an effective treatment for Graves' Disease?

Research has shown that IMVT-1402, which participants in this trial may receive, may help treat Graves' Disease. Studies found that patients experienced significant symptom improvement. Notably, a high dose of the treatment led to a clear reduction in eye bulging after 12 weeks. Importantly, participants generally tolerated the treatment well, suggesting it is likely safe. While more information is needed for a complete understanding, these early results are promising for those considering joining ongoing trials.13567

Are You a Good Fit for This Trial?

This trial is for adults with Graves' disease who have finished a previous IMVT-1402 study (either IMVT-1402-2502 or IMVT-1402-2503). Participants must meet additional specific requirements set by the study protocol.

Inclusion Criteria

I completed Study IMVT-1402-2502 or IMVT-1402-2503.
I meet other specific requirements listed in the study details.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Extension

Participants continue treatment with IMVT-1402 to evaluate efficacy and safety

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMVT-1402

Trial Overview

The study is testing the long-term safety and effectiveness of the drug IMVT-1402 in people with Graves' disease. Participants are placed into one of three groups based on their condition at the end of their earlier trial.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group AExperimental Treatment1 Intervention
Group II: Group BActive Control1 Intervention
Group III: Group CActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials
12
Recruited
1,400+

Citations

NCT07018323 | A Study to Assess the Efficacy, Safety, and ...

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

Immunovant Announces Phase 3 Study Results for ...

Topline data from the potentially registrational studies of IMVT-1402 in Graves' disease are expected in calendar year 2027. Immunovant ...

A Long-Term Extension Study of IMVT-1402 in Adult ...

This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) ...

Study To Assess The Efficacy, Safety, And Tolerability Of ...

The purpose of this study is to evaluate the efficacy of IMVT-1402 as treatment for adult patient Graves' Disease.

Immunovant Announces Phase 3 Study Results for ...

Patients in the TED studies had greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the ...

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT ...

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite ...

Immunovant Unveils Durability and Treatment-Free Six ...

Two potentially registrational trials of Immunovant's lead compound IMVT-1402 in Graves' disease will evaluate 600 mg dose for up to 52 weeks ...