Long-term clinical trial on tolerability, toxicity, pharmacokinetics and molecular mechanisms of action of EPI-EE
This research study is testing a new treatment called EPI-EE. It's for people with a condition called Eosinophilic Oesophagitis, which is a long-term problem causing inflammation in the gullet (the tube connecting your mouth to your stomach). This is an early-stage study, meaning it's one of the first times it's being tested in people. Scientists want to carefully check if EPI-EE is safe, what side effects it might have, and how your body reacts to it. They also want to understand how it works at a tiny, molecular level to help reduce inflammation. The aim is to gather important information before it can be tested in more people.
At a glance
What is this study about?
This study is researching a new medicine called EPI-EE. It's designed to help people who have Eosinophilic Oesophagitis, often shortened to EoE. EoE is a long-term condition where a type of white blood cell, called an eosinophil, builds up in the lining of the gullet (the tube that carries food from your mouth to your stomach). This build-up causes swelling and damage, making it hard to swallow and sometimes causing pain. This study is an early step to see if EPI-EE could be a helpful treatment for EoE.
This kind of study is called a 'Phase 1' study. This means it's one of the first times the treatment is being given to people. The main goals are to carefully check how safe EPI-EE is and to understand any potential side effects. Researchers will also look at how your body processes the medicine – how much stays in your system, and how it's broken down and removed.
Another important aim is to understand exactly how EPI-EE works within the body to fight the inflammation related to EoE. By looking at these very detailed processes, scientists hope to learn more about the condition itself and how new treatments can help. The information from this study will be crucial for deciding if EPI-EE should be tested further in larger studies with more people.
Key takeaways
- This study is testing a new treatment (EPI-EE) for Eosinophilic Oesophagitis (EoE).
- It's an early-stage (Phase 1) human study, focusing on safety and how the treatment works.
- Participants must be 18 years or older, with no upper age limit, and can be male or female.
- Taking part involves clinic visits for treatment, tests, and monitoring.
- Potential benefits might include helping your EoE, but there are also potential risks/side effects.
- You can always withdraw from the study at any time.
Who may be eligible?
To be able to take part in this study, you need to meet certain requirements. First, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate.
Both men and women are welcome to join this study. The researchers want to make sure the treatment is tested across different groups of people.
Beyond age and sex, specific details about your health and your Eosinophilic Oesophagitis (EoE) condition would be needed to know if you can join. This would include things like how severe your EoE is, whether you have other health conditions, and what other medicines you might be taking. A medical team would review all these details carefully.
- Are you 18 years old or older?
- Do you have a diagnosis of Eosinophilic Oesophagitis (EoE)?
- Are you able to attend regular clinic appointments?
- Are you willing to follow study instructions, including taking medication and doing tests?
- Do you understand that this is an early-stage study of a new treatment?
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, it would involve several visits to the clinic or hospital. During these visits, you would receive the study medication, EPI-EE, and researchers would carry out various assessments. These assessments might include blood tests, physical examinations, and possibly tests to check your gullet. The medical team would be closely monitoring your health and any effects of the medication.
You would likely need to keep a diary of your symptoms and any side effects at home. There would also be follow-up appointments after you stop taking the medication to make sure you are well. The total duration of your involvement in the study, including all visits and follow-up, would be fully explained to you before you agree to take part.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is Eosinophilic Oesophagitis (EoE)?
EoE is a long-term condition where inflammation in the gullet (food pipe) makes it hard to swallow and can cause pain.
What is a 'Phase 1' study?
It's an early-stage study, usually among the first times a new treatment is tested in people. The main aim is to check its safety.
Will I definitely get the new treatment?
In some studies, participants might get a placebo (dummy treatment), but the study team will explain exactly what to expect in this trial.
How long will the study last for me?
The total time you spend in the study, including all visits and follow-up, will be fully explained before you agree to join.
Can I stop participating if I want to?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your other medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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