A three-year, multi-center, double-blind, extension study to evaluate the long-term safety and efficacy of ligelizumab in patients who completed ligelizumab’s Phase III studies in food allergy
This three-year study is continuing to look into a new investigational medicine called ligelizumab for people with food allergy. It's designed to understand the long-term safety and how well the treatment works. Participants will be those who have already completed previous studies of ligelizumab for food allergy. Over three years, researchers will carefully monitor any side effects and see how the medicine helps with managing food allergy symptoms. The study is also looking at how people's quality of life might be affected. This is a crucial step in understanding if ligelizumab could be a safe and effective treatment option in the future.
At a glance
What is this study about?
Imagine you have a food allergy, where your body reacts badly to certain foods. This study is testing a new medicine called ligelizumab, which aims to help people with food allergies. This particular study is a continuation for people who have already been involved in earlier studies of ligelizumab. It's a key part of understanding if this medicine can be safely used for a long time and if it truly helps people manage their food allergies.
The main goal of this study is to very carefully track any side effects that might happen while taking ligelizumab over three years. Researchers will also be looking at how well the medicine works, for example, by seeing if participants can tolerate small amounts of the food they are allergic to without having a bad reaction. They will also be asking about how people's day-to-day lives and overall well-being might change over time with the treatment.
This is a 'Phase III' study, which means it's one of the final stages of testing a new medicine before it might be considered for wider use. By gathering more information on its long-term effects, the researchers hope to confirm if ligelizumab could become a helpful treatment option for people living with food allergies.
Key takeaways
- This study is for adults with food allergy who previously took part in ligelizumab trials.
- It aims to understand the long-term safety and effectiveness of ligelizumab over three years.
- Participants will receive ligelizumab or a placebo and be closely monitored for side effects.
- The study will also assess how the treatment affects participants' quality of life.
- This is a crucial step to determine if ligelizumab can be a safe and effective long-term treatment.
Who may be eligible?
To be able to join this study, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can take part. Both men and women are welcome.
A key requirement is that you must have previously taken part in one of the earlier studies looking at ligelizumab for food allergy and have completed it successfully.
There might be other health reasons or medical conditions that could affect whether you can join, which the study team will discuss with you. Always speak to the study doctors to see if this study is right 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 18 years old or older?
- Have you already completed a previous study involving ligelizumab for food allergy?
- Are you able to attend regular clinic visits for three years?
- Are you comfortable receiving injections of study medication?
What does participation involve?
If you decide to take part, you would be involved in this study for three years. During this time, you would have regular visits to the clinic so the study team can check on your health and how the medicine is affecting you. You would likely receive the study medicine, ligelizumab, or a placebo (a dummy medicine) through an injection, as used in the previous studies.
Some visits might include tests to see how your body reacts to small amounts of the food you're allergic to, in a very controlled setting. You'll also be asked to complete questionnaires about your quality of life and how you're feeling. The study team will carefully monitor for any side effects throughout the entire three-year period. You might also be given standard emergency medicines like salbutamol or adrenaline (epinephrine) to have with you, should you experience an allergic reaction.
Potential risks and benefits
Locations (5)
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is ligelizumab?
Ligelizumab is an investigational medicine being tested to see if it can help people with food allergies.
How long will this study last?
This study will last for three years.
Do I have to take part if I've been in a previous study?
No, taking part is always your choice. You don't have to join even if you were in an earlier study.
What's the main thing the study is looking for?
The main goal is to check how safe the medicine is over a long time and how often people have side effects.
Will I get emergency medicine?
Yes, you might be given emergency medicines like adrenaline (epinephrine) to have with you, just in case.
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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