A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
This research study is investigating a new medication called EP-104GI for adults who have eosinophilic esophagitis (EoE), a condition where a type of white blood cell called eosinophils build up in the gullet. The main goals are to check if the treatment is safe, how effective it is in reducing EoE symptoms and inflammation, and how it behaves in the body. Participants will either be given EP-104GI or a placebo (a dummy treatment). The study will involve several visits over about a year, potentially longer for some, and will include examinations of the gullet, blood tests, and questionnaires to understand the treatment's effects. It's a key step in developing new ways to manage EoE.
At a glance
What is this study about?
This study is looking into a new treatment for adults who have Eosinophilic Esophagitis, often shortened to EoE. EoE is a condition where a specific type of white blood cell, called eosinophils, build up in the lining of the gullet (oesophagus). This can lead to symptoms like difficulty swallowing, food getting stuck, and pain when swallowing. The new treatment being tested is called EP-104GI. The researchers want to find out if it's a safe and effective way to help people with EoE.
The study has two main parts. Initially, a small group of participants will help researchers understand the best and safest dose of EP-104GI. They will then expand to a larger group. In the second part, participants will be randomly assigned to receive either EP-104GI at one of two different doses, or a 'matching vehicle control', which is like a dummy treatment without the active drug. This allows researchers to compare the new treatment's effects against not having the active drug.
The main aim is to see how well EP-104GI works to reduce the inflammation in the gullet caused by EoE and to improve symptoms. Researchers will also be checking carefully for any side effects and how the body processes the medication. Understanding these things is crucial for developing new and better options for people living with EoE.
Key takeaways
- This study is testing a new treatment (EP-104GI) for adults with Eosinophilic Esophagitis (EoE).
- It aims to understand if the treatment is safe, how well it works, and how the body handles it.
- Participation involves endoscopy procedures, blood tests, and symptom questionnaires over about a year.
- You might receive the new treatment or a dummy version; some may switch to the active drug later.
- Eligible participants must be 18-75 years old with symptomatic EoE and meet specific health criteria.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Eosinophilic Esophagitis (EoE) that is causing you symptoms. If you're a woman who could become pregnant, you'll need to make sure you're using effective birth control and have a negative pregnancy test to take part.
There are certain reasons why you might not be able to join the study. For example, if you have other serious digestive conditions or infections in your mouth or gullet, or if you have severe swallowing problems not related to EoE that would make examinations difficult. Also, if you have certain medical conditions that mean you shouldn't take steroids, or if you're allergic to any of the ingredients in the study medication, you wouldn't be able to participate.
The study requires you to be able to stick to the planned schedule of visits and procedures. You also need to be able to understand the study and agree to take part after having all your questions answered.
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 between 18 and 75 years old?
- Do you have a diagnosis of Eosinophilic Esophagitis (EoE) with symptoms?
- If you're a woman who could become pregnant, are you willing to use effective birth control?
- Are you generally in good health apart from your EoE, without certain other serious medical conditions?
- Are you able to attend regular study visits for approximately one year?
- Are you NOT allergic to corticosteroids or other listed ingredients?
What does participation involve?
If you decide to take part, you'll be involved for about 52 weeks, which is roughly a year, though some people might have additional check-ups for up to two years. During this time, you'll have between 8 and 10 visits to the study site. Some people will be asked to come for up to 4 more visits for extra blood tests.
At the start, and at certain points depending on which part of the study you're in, you will have a procedure called an Endoscopy (EGD). This is where a thin, flexible tube with a camera is passed down your gullet to look at it closely and take small tissue samples (biopsies). The study medication (EP-104GI) or the dummy treatment will be given directly into your gullet during this endoscopy. You will also have regular blood and urine tests to check your overall health and how your body is handling the medication.
Throughout the study, you'll be asked to fill out questionnaires about your swallowing difficulties and any pain you might experience when swallowing. Your safety will be checked very frequently. If you are initially given the dummy treatment in the later part of the study, you might have the chance to switch to receiving the active EP-104GI treatment after 24 weeks if it's deemed safe for you to do so.
Potential risks and benefits
Locations (23)
- Campbelltown Private HospitalVerified postcodeSydney, Australia· Recruiting
- Mater Hospital BrisbaneVerified postcodeBrisbane, Australia· Recruiting
- Princess Alexandra HospitalVerified postcodeBrisbane, Australia· Recruiting
- Coastal Digestive HealthVerified postcodeMaroochydore, Australia· Recruiting
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Eastern Health Box HillVerified postcodeBox Hill, Australia· Recruiting
- Northern Hospital EppingVerified postcodeEpping, Australia· Recruiting
- The Alfred HospitalVerified postcodeMelbourne, Australia· Recruiting
- Royal Melbourne HospitalVerified postcodeParkville, Australia· Recruiting
- University of CalgaryVerified postcodeCalgary, Canada· Recruiting
- UoA - South Edmonton Gastroenterology Research ClinicVerified postcodeEdmonton, Canada· Recruiting
- G.I. Research InstituteVerified postcodeVancouver, Canada· Recruiting
Common questions
What is Eosinophilic Esophagitis (EoE)?
EoE is a long-term condition where a type of white blood cell, called eosinophils, builds up in the lining of your gullet (oesophagus), causing inflammation and symptoms like difficulty swallowing.
What is EP-104GI?
EP-104GI is the new treatment being tested in this study. Researchers are trying to find out if it's safe and effective for treating EoE.
Will I definitely receive the new treatment?
In some parts of the study, you might receive EP-104GI, or you might receive a 'matching vehicle control', which is a dummy treatment without the active drug. This helps researchers compare its effects.
What is an endoscopy?
An endoscopy (EGD) is a procedure where a thin, flexible tube with a camera is passed down your gullet to look inside and take small tissue samples. It's used to check the condition of your gullet and to give the study medicine.
How long does the study last?
The main part of the study lasts about a year (52 weeks), with some participants having extra check-ups for up to two years.
How to find out more
Pranali Ravikumar, MS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.