RecruitingPHASE3INTERVENTIONAL

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

This research study is investigating a new medication called efgartigimod for people with myasthenia gravis who currently rely on IVIG treatment. The main goal is to find out if efgartigimod is as effective as IVIG in managing symptoms and if patients prefer it. Researchers will also be checking how safe efgartigimod is and if people can tolerate it well over six months. Participants will have their usual IVIG stopped one week before starting the new drug. They will then receive regular efgartigimod infusions, with breaks in between, for about 24 weeks. Throughout the study, doctors will monitor how their myasthenia gravis symptoms are changing and their overall quality of life. Other medications for myasthenia gravis will stay the same during the study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Clinique Neuro-Outaouais

Enrolment target

Start

06 Feb 2025

Estimated completion

06 Jan 2027

Myasthaenia Gravis

What is this study about?

If you have myasthenia gravis, you might be familiar with treatments like IVIG that help manage your condition. This study is exploring a new medication called efgartigimod. The aim is to see if efgartigimod could be a good alternative to IVIG for people whose myasthenia gravis is stable and who need ongoing IVIG treatment.

The main questions this study wants to answer are: Does efgartigimod work as well as IVIG in controlling myasthenia gravis symptoms? Do patients prefer efgartigimod over IVIG? And is efgartigimod safe and easy to take over a six-month period? The study will carefully compare its effects to your current IVIG treatment.

This is an 'open label' study, which means both you and your doctors will know you are receiving efgartigimod. This research is important because it could lead to new ways to treat myasthenia gravis, potentially offering more options for patients in the future.

Key takeaways

This study explores a new drug (efgartigimod) for myasthenia gravis.
It aims to see if efgartigimod can replace IVIG treatment.
Researchers will compare effectiveness, safety, and patient preference.
The study lasts 26 weeks, involving regular infusions and breaks.
Other myasthenia gravis medications will usually remain unchanged.

Who may be eligible?

This study is looking for adults aged between 18 and 80 years old who have myasthenia gravis. To be considered, your myasthenia gravis must be stable, meaning your symptoms and treatment with IVIG haven't changed much in the last four months. You also need to have specific antibodies in your blood (called acetylcholine receptor antibodies) and have been regularly receiving IVIG treatments for at least a year.

There are also some reasons why you might not be able to join. For example, if you've had certain other myasthenia gravis treatments recently (like rituxan or eculizumab). You also can't take part if you've had a specific surgery called a thymectomy in the last three months, or if you have certain active infections like Hepatitis B or C, or untreated tuberculosis.

People who are pregnant or planning to get pregnant in the next six months cannot participate. Those with severe kidney problems or very low levels of a certain antibody (IgG) in their blood will also be excluded. Ultimately, your doctor will decide if this study is suitable for you.

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.

Are you between 18 and 80 years old?
Has your myasthenia gravis been stable for at least 4 months?
Have you been regularly receiving IVIG for over a year?
Are you able to commit to weekly assessments and infusions for part of the study?
Are you not pregnant or planning to become so within 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, your current IVIG treatment will be stopped one week before the study officially starts. Other medications you take for myasthenia gravis, such as non-steroid immunosuppressant therapies, acetylcholinesterase inhibitors, or corticosteroids, will stay the same throughout the study.

You will receive efgartigimod as an infusion into a vein, given at a hospital or clinic. This will happen once a week for four weeks. After these four infusions, you'll have a four-week break from the medication. This cycle of four weeks of infusions followed by a four-week break will repeat four times in total, lasting about 24 weeks. After the last treatment, there will be a two-week observation period, with a final visit at week 26.

Throughout the study, you will have weekly checks to assess your myasthenia gravis symptoms and how they affect your daily life. This helps the doctors understand how well the new medication is working for you. So, expect regular visits and assessments over the 26-week period.

Potential risks and benefits

Taking part in this study could offer several benefits. You would be among the first to try a new treatment for myasthenia gravis that might work as well as or better than your current IVIG. This could potentially offer you a different way to manage your condition. However, as with any new medication, there are potential risks and side effects that are not yet fully known. The study will carefully monitor your safety and any reactions you might have. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinique Neuro-Outaouais
Verified postcode
Gatineau, Canada· Recruiting

Common questions

What is myasthenia gravis?

Myasthenia gravis is a long-term condition that causes muscle weakness. It can affect muscles in the eyes, face, throat, and limbs.

What is IVIG?

IVIG stands for Intravenous Immunoglobulin. It's a treatment given into a vein that uses antibodies from healthy donors to help calm the immune system.

What is 'stable disease'?

Stable disease means your myasthenia gravis symptoms haven't significantly worsened or changed, and your IVIG treatment frequency and dose have been consistent for a while.

Will I have to stop all my other myasthenia gravis medications?

No, you will only stop your IVIG. Other medications you take for myasthenia gravis will stay the same during the study.

How long will I be in the study?

The study will last for a total of 26 weeks, which is about six months.

How to find out more

François Jacques, Doctor

francois.jacques@neuro-outaouais.ca 819-777-2500 Official trial record

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