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Study on BP1.7881 for Adults with Eosinophilic Esophagitis

Fast replyInvestigationalNo placebo

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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.

Step 1
Joining the trial
Upon joining the trial, informed consent is required. This involves understanding the trial's purpose and agreeing to participate.
Eligibility criteria include being 18 years or older, having symptoms of eosinophilic esophagitis (EoE) for at least four weeks, and a confirmed diagnosis of EoE during screening.
Step 2
Initial assessment
An initial assessment is conducted to confirm the diagnosis of eosinophilic esophagitis. This may involve an esophagogastroduodenoscopy, a procedure to examine the esophagus, stomach, and upper part of the small intestine, along with biopsies.
Step 3
Randomization and medication
Participants are randomly assigned to receive either the investigational medication BP1.7881 or a placebo. The medication is administered in the form of an orodispersible tablet, which dissolves in the mouth.
The dosage and frequency of administration are determined by the trial protocol, and participants are required to adhere to the prescribed regimen.
Step 4
Treatment period
The treatment period lasts for 12 weeks. During this time, participants continue taking the assigned medication and attend regular follow-up visits to monitor progress and any side effects.
Step 5
Follow-up assessments
Throughout the trial, participants undergo various assessments to evaluate the effectiveness of the treatment. These include changes in symptoms, endoscopic findings, and histological analysis of esophageal tissue.
The primary goal is to achieve a reduction in eosinophil count in the esophagus, with secondary goals including improvements in symptom scores and endoscopic appearance.
Step 6
Completion of trial
At the end of the 12-week treatment period, a final assessment is conducted to evaluate the overall outcomes of the trial.
Participants may be required to continue follow-up for a specified period to monitor any long-term effects of the treatment.

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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

BP1.7881 is an investigational medication being studied for its potential to reduce inflammation in the esophagus caused by eosinophilic esophagitis. This condition involves an increased number of eosinophils, a type of white blood cell, in the esophagus, leading to symptoms like difficulty swallowing and food getting stuck. The trial aims to assess how well BP1.7881 can decrease the number of these cells in the esophageal tissue, potentially improving symptoms for patients.

Bp1.7881A

What is already known about the treatment

BP1.7881 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating eosinophilic esophagitis, a condition characterized by inflammation of the esophagus due to an excess of eosinophils. The main therapeutic indication for BP1.7881 is to reduce eosinophil infiltration in the esophageal tissue, which is the primary objective of the ongoing trial. At the molecular level, BP1.7881 is believed to work by modulating the immune response, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is still in the phase 2 trial stage and not yet approved for general medical use.

Investigated diseases

Eosinophilic esophagitis – Eosinophilic esophagitis is a chronic immune system disease where a type of white blood cell, called eosinophil, builds up in the lining of the esophagus. This accumulation is often a reaction to foods, allergens, or acid reflux and can lead to inflammation. Over time, the inflammation can cause the esophagus to become narrow and stiff, making it difficult to swallow. Symptoms may include difficulty swallowing, food getting stuck in the esophagus, and chest pain. The condition can affect people of all ages, but it is more common in males. It is often diagnosed in children and young adults.