Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
This study, called RAISE-XT, is for existing participants in a trial looking at a medicine called zilucoplan. It focuses on people living with a muscle weakness condition known as generalized myasthenia gravis (gMG). The main goal is to understand how well zilucoplan works and how safe it is over a longer period. By continuing to follow people who have already taken the medicine, researchers can gather important information about its long-term effects. This helps us learn more about zilucoplan as a treatment option for gMG, hoping to improve care for those with the condition. It’s an extension of previous studies, meaning it continues to observe people who have already started the treatment.
At a glance
What is this study about?
This study, known as RAISE-XT, is designed for people who have generalized myasthenia gravis (gMG) and have already taken part in a previous study testing a medicine called zilucoplan. Generalized myasthenia gravis is a condition that causes muscle weakness in different parts of the body, which can make everyday tasks difficult. Zilucoplan is a new treatment being investigated for this condition. The earlier studies looked at how zilucoplan worked over a shorter period.
This new study is an 'open-label extension', which means that participants and the study team will know that everyone involved is receiving zilucoplan. It's about seeing how the medicine works and if it's safe when used for a longer time. By continuing to gather information from people who have already tried zilucoplan, researchers hope to get a clearer picture of its long-term benefits and any side effects.
The main aim is to understand if zilucoplan can help manage gMG symptoms effectively over many months or even years, and if it continues to be a safe treatment option. This kind of long-term study is very important because it helps doctors and patients make informed decisions about treatments for chronic conditions like gMG, ultimately aiming to improve quality of life.
Key takeaways
- This study is for long-term follow-up of zilucoplan.
- It's for people with generalized myasthenia gravis.
- You must have been in a previous zilucoplan study.
- The goal is to check long-term safety and how well it works.
- You'll be closely monitored by doctors.
- You can stop participating at any time.
Who may be eligible?
This study is specifically for adults who have already taken part in a study for zilucoplan, a medicine being tested for generalized myasthenia gravis. If you've been in one of those previous zilucoplan studies, you might be able to join this one.
You cannot join this study if you are currently taking part in another clinical trial where you are receiving an experimental treatment. This is to make sure that any effects seen are clearly due to zilucoplan and not another new medicine. However, you can still be in studies that are just observing health or collecting information, as long as they don't involve new medicines.
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.
- I have generalized myasthenia gravis.
- I have already participated in an earlier study for zilucoplan.
- I am 18 years old or older.
- I am not currently taking part in another study testing a new experimental medicine.
What does participation involve?
If you decide to join this study, you will continue to receive the medicine zilucoplan. The study team will regularly check your health, how your generalized myasthenia gravis symptoms are doing, and if you have any side effects. This will involve regular visits to the study clinic, where you might have physical exams, blood tests, and answer questions about your well-being. The exact number and frequency of visits, as well as the total length of your participation, will be clearly explained by the study team. They will continue to monitor your progress over an extended period to understand the long-term effects of zilucoplan.
Potential risks and benefits
Locations (70)
- Mg0011 41Verified postcodeMobile, United States
- Mg0011 116Verified postcodePhoenix, United States
- Mg0011 31Verified postcodeIrvine, United States
- MG0011 4Verified postcodeLos Angeles, United States
- Mg0011 220Verified postcodePasadena, United States
- Mg0011 160Verified postcodeSan Francisco, United States
- Mg0011 24Verified postcodeNew Haven, United States
- Mg0011 27Verified postcodeWashington D.C., United States
- Mg0011 25Verified postcodeTampa, United States
- Mg0011 135Verified postcodeAugusta, United States
- Mg0011 188Verified postcodeGlenview, United States
- Mg0011 156Verified postcodeIndianapolis, United States
Common questions
What is 'open-label'?
Open-label means that everyone involved, including you and the study doctors, knows that you are receiving the study medicine, zilucoplan.
Who is zilucoplan for?
Zilucoplan is a medicine being studied for people who have generalized myasthenia gravis, a condition causing muscle weakness.
Can I join if I'm on another new medicine?
No, you cannot join if you are currently taking part in another study that tests an experimental treatment.
What does a 'Phase 3' study mean?
Phase 3 is usually one of the final steps in testing a new medicine, looking at its effectiveness and safety in a larger group of people before it might become widely available.
What happens after the study ends?
The study team will explain what medical care options are available to you once your participation in the study is complete.
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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