RecruitingPHASE3INTERVENTIONAL

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

This study is looking at a new medicine called IMVT-1402 for adults who have a health condition known as generalized myasthenia gravis, which causes muscle weakness. Researchers want to find out if this medicine is both safe to use and effective at helping people manage their symptoms better. It's a phase 3 study, meaning it's one of the final steps before a medicine might be made widely available. Participants will be given either the new medicine or a dummy treatment (placebo) to compare their effects. The goal is to see if IMVT-1402 can improve how people with myasthenia gravis feel and their ability to carry out everyday activities.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Immunovant Sciences GmbH

Enrolment target

231

Start

27 May 2025

Estimated completion

01 Dec 2028

Generalized Myasthenia Gravis

What is this study about?

This study is about a health condition called generalized myasthenia gravis (gMG). If you have gMG, your body's immune system mistakenly attacks your muscles, leading to weakness. This can make simple daily tasks, like walking, talking, or even smiling, difficult. Researchers hope to find a way to make life easier for people with gMG.

The study is testing a new medication called IMVT-1402. It's a 'Phase 3' study, which means it's one of the last stages of testing before a new medicine can be considered for wider use. During the study, some participants will receive IMVT-1402, while others will receive a 'placebo' – a dummy treatment that looks like the real medicine but contains no active drug. This allows the researchers to fairly compare the effects of the new medicine against no active treatment.

The main aim is to understand if IMVT-1402 is safe and if it helps reduce the muscle weakness and other symptoms of gMG. They will be looking at whether people's symptoms improve and if they can do everyday activities more easily. This information is really important for doctors and patients to decide if this new treatment could be a good option in the future.

Key takeaways

This study is for adults (18-80) with mild to severe generalized myasthenia gravis.
It's testing a new medicine, IMVT-1402, to see if it's safe and effective.
Participation involves regular clinic visits, medical checks, and possibly receiving a placebo.
The aim is to find better treatments for myasthenia gravis symptoms.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old and have mild to severe generalized myasthenia gravis. You also need to be able to understand what's involved in the study and be willing to follow the study plan. Your myasthenia gravis symptoms should be affecting your daily activities to a certain degree, as measured by a specific score doctors use.

There are some reasons why you might not be able to join. For example, if you've recently had a serious worsening of your myasthenia gravis, known as a myasthenic crisis, within the last 12 weeks. Also, if you've had a specific type of surgery called a thymectomy in the last six months, or if you're planning to have one during the study, you wouldn't be able to take part. Finally, if you have a certain kind of tumour called an untreated malignant thymoma, you might also not be eligible.

Your study doctor will discuss all the detailed requirements with you to make sure the study is a safe and suitable option for you.

Quick self-check

Are you between 18 and 80 years old?
Do you have a diagnosis of generalized myasthenia gravis (gMG)?
Are your gMG symptoms affecting your daily activities?
Have you *not* had a myasthenic crisis in the last 12 weeks?
Have you *not* had specific chest surgery (thymectomy) in the last 6 months, and don't plan to during the study?
Do you *not* have an active untreated malignant thymoma?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the new medicine (IMVT-1402) or a placebo (a dummy treatment). You won't know which one you're getting. You'll have regular visits to the study clinic, where doctors and nurses will check your health, assess your symptoms, and monitor for any side effects. You'll likely undergo various tests, which could include blood tests, physical examinations, and questionnaires about how you're feeling and your daily activities. The study will involve several months of treatment and follow-up, and you'll receive detailed information about the schedule of visits and assessments before you commit.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new medicine for your myasthenia gravis that might improve your symptoms, or getting closer medical attention and care. However, like all medicines, IMVT-1402 may have side effects, and some risks are currently unknown. You might also receive a placebo and therefore not experience any direct benefit from the study drug itself. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (83)

Site Number - 1056
Huntsville, United States· Recruiting
Site Number - 1041
Mobile, United States· Recruiting
Site Number - 1017
Phoenix, United States· Recruiting
Site Number - 1025
Scottsdale, United States· Recruiting
Site Number - 1042
Tucson, United States· Recruiting
Site Number - 1010
Carlsbad, United States· Recruiting
Site Number - 1028
Irvine, United States· Recruiting
Site Number - 1023
Los Angeles, United States· Recruiting
Site Number - 1029
Rancho Mirage, United States· Recruiting
Site Number - 1004
San Francisco, United States· Recruiting
Site Number - 1027
Fort Collins, United States· Recruiting
Site Number - 1001
New Haven, United States· Recruiting

+71 more sites — see the official record for the full list.

Common questions

What is generalized myasthenia gravis (gMG)?

It's a long-term condition where your body's immune system attacks your muscles, leading to weakness that can affect daily activities.

What is IMVT-1402?

It's a new medicine being tested in this study to see if it can help people with gMG.

What does 'Phase 3 study' mean?

It means this is one of the final stages of testing a new medicine before it might be made widely available to patients.

Will I know if I'm getting the medicine or a dummy treatment?

No, you won't know if you're receiving the active medicine or a 'placebo' (dummy treatment). This is to ensure fair and accurate results.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

Central Study Contact

clinicaltrials@immunovant.com 18007970414 Official trial record

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