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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying eosinophilic esophagitis, a condition where a type of white blood cell called eosinophil builds up in the esophagus, leading to inflammation and difficulty swallowing. The trial will evaluate a new treatment called BP1.7881A, which is taken as an orodispersible tablet, meaning it dissolves in the mouth. The purpose of the study is to assess the effectiveness and safety of BP1.7881A in treating adults with eosinophilic esophagitis.
Participants in the study will be randomly assigned to receive either the BP1.7881A tablet or a matching orodispersible placebo tablet. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The trial will last for a period of 12 weeks, during which participants will undergo regular check-ups and assessments to monitor changes in their condition.
The main goal of the trial is to observe any changes in the number of eosinophils in the esophageal tissue, which will be measured through biopsies. Additionally, the study will track improvements in symptoms such as difficulty swallowing and other related issues. Participants will be asked to complete questionnaires and undergo endoscopic procedures to help gather this information. The trial aims to provide valuable insights into the potential benefits of BP1.7881A for individuals with eosinophilic esophagitis.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Provide written informed consent before any trial-related procedures begin. This means you agree to participate after understanding the study details.
- Be a male or female who is 18 years old or older.
- Have symptoms related to eosinophilic esophagitis (EoE) for at least the last 4 weeks before the screening. Symptoms may include difficulty swallowing that requires liquids, coughing or gagging, vomiting, or needing medical help to feel better.
- Have a confirmed diagnosis of eosinophilic esophagitis (EoE) at the screening.
- The study doctor believes you will follow the trial procedures, which include having two esophagogastroduodenoscopies with biopsies. This is a procedure where a doctor looks inside your esophagus, stomach, and the first part of your small intestine using a camera.
- Be willing to cooperate and follow all trial requirements and procedures, such as completing questionnaires, taking the study medication as directed, and not using medications that are not allowed during the trial.
- If you are a female, you must either be post-menopausal, meaning you have not had a menstrual period for at least 12 months naturally, or if you can become pregnant, you must use a highly effective method of birth control during the trial and for one month after stopping the study medication.
- If needed, you must have appropriate national health insurance coverage.
Who cannot join the trial?
4 criteria
- Individuals who do not have eosinophilic esophagitis cannot participate. This is a condition where a type of white blood cell called an eosinophil builds up in the esophagus, which is the tube that carries food from the mouth to the stomach.
- Participants must be within certain age ranges, specifically between 3 and 4 years old.
- Both males and females are eligible, but certain groups may be excluded based on specific criteria not listed here.
- Individuals who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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What is already known about the treatment
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