A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
This research study is about a new medicine, Batoclimab, for adults who have a condition called generalized Myasthenia Gravis (gMG). This condition causes muscle weakness. The study aims to find out if Batoclimab can effectively improve symptoms and daily activities for people with gMG, and if it's safe to use. Some participants will receive the new medicine, while others will receive a dummy medicine (placebo) that looks exactly the same but has no active ingredients. This helps researchers fairly compare how well the new medicine works. The study will look closely at changes in how participants manage daily tasks and other symptoms over several weeks.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment called Batoclimab for adults living with generalized Myasthenia Gravis (gMG). gMG is a condition that causes muscles to become weak and tired, which can make everyday activities challenging. The main goal of this study is to see if Batoclimab can effectively reduce these symptoms and improve a person's ability to carry out daily tasks, like eating, speaking, or walking. Researchers also want to make sure the treatment is safe to use.
To get a clear picture of how well Batoclimab works, the study is set up so that some people will receive the actual medicine, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This is a common and important practice in medical research – by comparing the two groups, scientists can be more confident that any improvements are due to the medicine itself, and not just chance or people feeling better because they are part of a study.
The study will carefully track how participants' symptoms change over several weeks. They will use special scores that measure how gMG affects daily activities and overall muscle strength. This will help them understand if Batoclimab makes a real difference in people's lives and whether it could become a new treatment option for generalized Myasthenia Gravis.
Key takeaways
- The study is for adults with generalized Myasthenia Gravis (gMG).
- It's testing a new medicine called Batoclimab.
- The aim is to see if Batoclimab improves daily activities and is safe.
- Some people will get Batoclimab, others a 'dummy' medicine (placebo).
- Participation involves regular clinic visits and monitoring.
- You can leave the study at any time.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.
Beyond these basic requirements, there will be other specific health checks and medical history questions to make sure the study is a good fit for you and that taking part would be safe. For example, doctors will need to confirm you have generalized Myasthenia Gravis.
It's important to remember that not everyone who has gMG will be able to join. The research team will carefully review each potential participant's medical information to ensure they meet all the study's specific criteria. This helps to protect your safety and ensure the study results are as accurate as possible.
- Are you 18 years old or older?
- Have you been diagnosed with generalized Myasthenia Gravis (gMG)?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially receive a placebo?
- Have you discussed your current medications with your doctor?
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 will likely have regular visits to the clinic over a number of weeks. During these visits, the study team will: * Ask you questions about how you are feeling and how your gMG symptoms are affecting you. * Perform physical examinations to check your muscle strength. * Take blood samples. * Give you the study medication (either Batoclimab or the placebo) as directed. * Carefully monitor you for any changes in your health or any side effects.
The study involves two main periods of treatment and monitoring, followed by a longer term follow up. The total time you would be involved in the study would be explained in detail by the study team, but it's likely to be several months. You would continue to be monitored even after the main treatment phase.
Potential risks and benefits
Locations (6)
- —Romania
- —Germany
- —Italy
- —Poland
- —Spain
- —Hungary
Common questions
What is Myasthenia Gravis (gMG)?
It's a long-term condition that causes muscle weakness and tiredness, affecting daily activities like blinking, speaking, and walking.
What is Batoclimab?
Batoclimab is a new medicine being tested to see if it can help improve symptoms for people with gMG.
What does 'placebo' mean?
A placebo is a dummy medicine that looks exactly like the real treatment but contains no active ingredients. It helps researchers compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor the doctors will know during the main part of the study. This is called 'quadruple-blind' and ensures the results are fair.
How long will the study last?
The study will involve several weeks of treatment and monitoring, with an overall duration of several months. The exact timeline will be discussed with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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