A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
This research study is for adults with a condition called Eosinophilic Oesophagitis, or EoE. This is where a type of white blood cell causes inflammation in your food pipe (oesophagus), making it hard to swallow. The study aims to find out if a medicine called dupilumab can help your food pipe work better and repair any damage, compared to a dummy medicine (placebo). It will last about 2.5 years in total. For the first 24 weeks, you'd either get dupilumab or the placebo. After that, everyone taking part will receive dupilumab for a longer period. We hope to better understand how this treatment can help people living with EoE.
At a glance
What is this study about?
This study is about a condition called Eosinophilic Oesophagitis (say: ee-oh-sin-oh-FILL-ick uh-SOFF-uh-GUY-tiss), often shortened to EoE. This happens when too many white blood cells, called eosinophils, build up in your food pipe (oesophagus). This causes inflammation and can make it difficult and painful to swallow food.
We are looking into a medicine called dupilumab. This study wants to see if dupilumab can improve how well your food pipe works and if it can help repair any changes or damage inside your food pipe caused by EoE. We will compare dupilumab with a placebo, which looks just like the medicine but contains no active drug, to understand its effects better.
The study will last for a total of 2 and a half years (128 weeks). For the first six months, participants will be randomly chosen to receive either dupilumab or the placebo. After this initial period, everyone taking part in the study will then receive dupilumab for the remaining two years. This long-term approach helps us understand the lasting effects of the treatment.
Key takeaways
- This study evaluates dupilumab for adults with Eosinophilic Oesophagitis (EoE).
- It lasts about 2.5 years, comparing dupilumab to a dummy medicine initially.
- The goal is to see if dupilumab improves swallowing and repairs food pipe damage.
- Participation involves clinic visits and potential home delivery of medicine.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you must be an adult aged 18 or over and have been diagnosed with Eosinophilic Oesophagitis (EoE) through a special examination (endoscopy) and a tissue sample (biopsy).
You should also have had difficulty swallowing solid food at least twice a week in the month before the study starts. Your body weight needs to be at least 40 kilograms (about 6 stone 4 pounds).
There are certain reasons why you might not be able to join. For example, if your EoE might be due to other conditions, or if you have certain other serious bowel or stomach conditions. You can’t have had specific treatments like swallowed steroids in the last 8 weeks, or changed your diet for EoE recently. If you've already taken dupilumab commercially or in another study, you won't be able to participate.
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 an adult aged 18 or over?
- Do you have a confirmed diagnosis of Eosinophilic Oesophagitis?
- Have you had trouble swallowing solid food at least twice a week recently?
- Have you avoided certain EoE medications (like swallowed steroids) in the past 8 weeks?
- Are you not currently taking dupilumab or have you not taken it in another study?
What does participation involve?
If you join the study, it will last for up to 152 weeks in total, which is nearly three years. Before starting the main study, there's a "screening period" of up to 12 weeks to check if you're suitable.
For the first 24 weeks, you'll be randomly assigned to either receive dupilumab or a dummy medicine (placebo), and neither you nor the study team will know which one you are getting. After these 24 weeks, everyone in the study will then receive dupilumab for another 104 weeks.
During the study, you will have ten visits to the study clinic. In addition, the study medicine will be sent directly to your home for five visits, unless local rules prevent it or you prefer to pick it up at the clinic. After you finish taking the study medicine, there will be a follow-up period of up to 12 weeks, or until you start taking dupilumab from a doctor outside the study, whichever happens first.
Potential risks and benefits
Locations (30)
- United Gastroenterologists - Murrieta- Site Number : 8400001Verified postcodeMurrieta, United States
- University of California San Francisco - Parnassus Heights- Site Number : 8400020Verified postcodeSan Francisco, United States
- Borland Groover Clinic- Site Number : 8400016Verified postcodeJacksonville, United States
- Treasure Valley Medical Research- Site Number : 8400018Verified postcodeBoise, United States
- Northwestern University- Site Number : 8400003Verified postcodeChicago, United States
- GI Alliance - Glenview- Site Number : 8400012Verified postcodeGlenview, United States
- Illinois Gastroenterology Group- Site Number : 8400004Verified postcodeGurnee, United States
- University of Iowa- Site Number : 8400006Verified postcodeIowa City, United States
- University of Massachusetts Chan Medical School- Site Number : 8400019Verified postcodeWorcester, United States
- Mayo Clinic Hospital Rochester- Site Number : 8400008Verified postcodeRochester, United States
- University of North Carolina at Chapel Hill- Site Number : 8400007Verified postcodeChapel Hill, United States
- Cleveland Clinic - Cleveland- Site Number : 8400009Verified postcodeCleveland, United States
Common questions
What is Eosinophilic Oesophagitis (EoE)?
It's a long-term allergic condition where white blood cells called eosinophils build up in your food pipe (oesophagus), causing inflammation and making swallowing difficult.
What is dupilumab?
Dupilumab is a medicine that aims to calm down the inflammation caused by EoE. It’s given as an injection.
What is a placebo?
A placebo is a dummy medicine. It looks exactly like the real medicine but contains no active drug, helping us understand how well the actual medicine works.
How long will I be in the study?
The study lasts for up to 2 and a half years in total, including screening and follow-up periods.
Will I know if I'm getting the real medicine or the placebo?
For the first 24 weeks, neither you nor the study doctors will know if you're getting dupilumab or the placebo. After that, everyone receives dupilumab.
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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