CDX0159-08: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)
This research study, named 'EvolvE', is testing a new medicine called barzolvolimab for adults who have Eosinophilic Oesophagitis (EoE). EoE is a long-term condition where a type of white blood cell, called eosinophils, build up in the food pipe, causing inflammation and problems with swallowing. We want to find out if this new medicine can help reduce these eosinophils and improve symptoms. Some people will receive the new medicine, while others will get a placebo, which looks like the medicine but contains no active ingredients. This helps us fairly compare the effects. The study will also carefully check for any side effects to make sure the medicine is safe. It's a 'Phase 2' study, meaning we're still in the early stages of testing this treatment.
At a glance
What is this study about?
This study is about a condition called Eosinophilic Oesophagitis, often shortened to EoE. If you have EoE, it means you have too many special infection-fighting cells, called eosinophils, in the lining of your food pipe (oesophagus). This causes inflammation, which can make it hard or painful to swallow food.
The study is testing a new medicine called barzolvolimab. We want to see if this medicine can help lower the number of these eosinophil cells in your food pipe and ultimately help improve your symptoms. To do this, some people in the study will receive the new medicine, while others will get a 'placebo'. A placebo looks exactly like the medicine but doesn't contain any active drug. This is a common and important way to test new treatments, as it helps doctors tell if the new medicine is truly effective or if any changes are due to other factors.
This is a 'Phase 2' study. This means we're in an earlier stage of testing this medicine. We're looking closely at whether it works as expected to reduce the inflammation and if it's safe for people to use. Information from this study will help us understand if barzolvolimab could be a helpful treatment for EoE in the future.
Key takeaways
- Tests a new medicine (barzolvolimab) for Eosinophilic Oesophagitis.
- Compares the new medicine to a dummy treatment (placebo).
- Aims to reduce inflammation in the food pipe over 12 weeks.
- Checks for safety and effectiveness in adults.
- This is an early stage (Phase 2) study.
Who may be eligible?
This study is for adults aged 18 and older. Both men and women can take part.
To be eligible, you need to have active Eosinophilic Oesophagitis. This means your condition is currently affecting you, and there are signs of inflammation from the eosinophil cells in your food pipe.
The research team will carry out some checks to make sure the study is a good fit for you and that taking part would be safe.
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?
- Do you have a diagnosis of active Eosinophilic Oesophagitis?
- Are you willing to potentially receive a placebo?
- Are you able to attend regular clinic visits and assessments?
What does participation involve?
If you decide to take part, you'll be given either the new medicine (barzolvolimab) or a placebo, which is a dummy medicine. Neither you nor your study doctor will know which one you are getting. The medicine will be given as an injection using a special pen. We don't have details on how often or for how long you'd need the injections, or how many visits are involved, but typically these studies involve regular trips to the clinic for check-ups and to receive your treatment.
Over 12 weeks, the study team will closely monitor your condition. This will likely involve regular medical examinations, answering questions about your symptoms, and possibly having procedures like an endoscopy (where a tiny camera looks inside your food pipe) to see how the inflammation is changing. They will also keep a close eye on your health to check for any side effects.
The main goal is to see how much the number of eosinophil cells in your food pipe changes from the start of the study to week 12.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is Eosinophilic Oesophagitis?
It's a long-term condition where certain white blood cells (eosinophils) build up in your food pipe, causing inflammation and difficulty swallowing.
What is barzolvolimab?
It's a new medicine being tested to see if it can help reduce the inflammation in the food pipe caused by Eosinophilic Oesophagitis.
What is a 'placebo'?
A placebo looks like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine to see if it truly works.
Why is this a 'Phase 2' study?
Phase 2 means it's an earlier stage of testing, focusing on whether the medicine works well enough to treat the condition and if it's safe for people.
How long does the study last?
The main part of the study measures changes over 12 weeks, but the total duration of your participation, including follow-up, may be longer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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