ARGX-113-2003: A Phase 3B, Randomized, Open-Label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis
This study is for people living with generalised myasthenia gravis (gMG). We are testing different ways of giving a drug called efgartigimod, also known as Vyvgart, which is given through a drip (intravenous infusion). The main goal is to find out which way of giving Vyvgart works best to reduce gMG symptoms and help people feel better for longer. We will be looking closely at how participants' symptoms, like muscle weakness, change over time. We will also check for any side effects and monitor how safe the different dosing plans are. The study hopes to find the most effective and comfortable treatment plan for people with gMG.
At a glance
What is this study about?
This study is about a condition called generalised myasthenia gravis, or gMG. If you have gMG, your body's immune system mistakenly attacks its own healthy tissues, leading to muscle weakness. This can affect how you move, speak, swallow, and even breathe. The study is investigating a specific medicine named efgartigimod, which is also known by its brand name, Vyvgart. This medicine is given directly into your bloodstream through a drip, which is called an intravenous infusion.
The main aim of this study is to discover the best way to give Vyvgart to people with gMG. We want to find out if giving the medicine in different amounts or at different times can help people manage their symptoms better and improve their quality of life. The researchers will be carefully observing how your symptoms change and how well you feel over several weeks.
By comparing different treatment plans, the study hopes to identify the most effective and comfortable way to use Vyvgart. This could help doctors in the future to provide personalised treatment for people with gMG, helping them to live more fulfilling lives with fewer symptoms.
Key takeaways
- This study is for adults with generalised myasthenia gravis (gMG).
- It's testing different ways of giving the medicine efgartigimod (Vyvgart).
- The goal is to find the best dosing plan to improve gMG symptoms.
- Participation involves regular clinic visits and health checks.
- You will receive close medical monitoring throughout the study.
Who may be eligible?
This study is open to both men and women who have been diagnosed with generalised myasthenia gravis (gMG).
Participants need to be at least 18 years old. There is no upper age limit for joining the study, so older adults are welcome to take part too.
Beyond these basic requirements, there will be other specific medical checks to make sure the study is safe and suitable for you. A doctor involved in the study will discuss these in more detail to confirm if you can participate.
- Are you 18 years old or older?
- Do you have a diagnosis of generalised myasthenia gravis (gMG)?
- Are you able to attend regular clinic appointments?
- Are you willing to receive treatment through an intravenous drip?
- Are you comfortable having your health and symptoms closely monitored?
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 in this study, you'll be given the study drug efgartigimod (Vyvgart) through a drip. The study will involve regular visits to a clinic over several weeks. During these visits, doctors and nurses will closely monitor your general health, check your gMG symptoms, and record any changes you experience. They will perform various assessments, such as checking your blood, taking your blood pressure, and performing heart scans (ECGs).
The study will compare different ways of giving the treatment – for example, how much is given or how often. You will be assigned to one of these treatment plans. Your participation will involve keeping track of your symptoms and how you feel, which might include filling out questionnaires. The total duration of your involvement in the study will be explained in detail by the study team, along with what follow-up appointments may be needed after your treatment period.
Potential risks and benefits
Locations (7)
- —Spain
- —Italy
- —Austria
- —Germany
- —Belgium
- —France
- —Poland
Common questions
What is generalised myasthenia gravis (gMG)?
Generalised myasthenia gravis (gMG) is a long-term condition that causes muscle weakness throughout your body because your immune system mistakenly attacks your own tissues.
What is efgartigimod (Vyvgart)?
Efgartigimod, also known as Vyvgart, is a medicine used to treat gMG. In this study, it is given directly into your bloodstream using a drip.
Why is this study being done?
This study aims to find the best way to give Vyvgart to people with gMG to help them manage their symptoms and feel better for longer.
Will I have to pay to be in the study?
No, you will not have to pay for the study treatment or the care you receive as part of the study.
Can I leave the study at any time?
Yes, you are free to leave the study at any point and for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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