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Study on the Safety and Effectiveness of Dupilumab for Adults and Adolescents with Eosinophilic Gastritis and Eosinophilic Duodenitis

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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 the effects of a medication called dupilumab on a condition known as eosinophilic gastritis, which may occur with or without eosinophilic duodenitis. Eosinophilic gastritis is a condition where a type of white blood cell, called an eosinophil, builds up in the stomach lining, causing inflammation and discomfort. Eosinophilic duodenitis is similar but occurs in the first part of the small intestine. The study will compare the effects of dupilumab, which is given as a solution for injection, to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if dupilumab is safe and effective in treating adults and adolescents with eosinophilic gastritis, with or without eosinophilic duodenitis. Participants in the study will receive either dupilumab or a placebo over a period of up to 52 weeks. The study is divided into three parts, with each part focusing on different aspects of treatment and safety. Throughout the study, participants will undergo various assessments to monitor the effects of the treatment on their condition.

Participants will receive regular injections and will be monitored for changes in their symptoms and any side effects. The study aims to provide valuable information on how well dupilumab works in reducing the symptoms and inflammation associated with eosinophilic gastritis and eosinophilic duodenitis. This research could lead to better treatment options for individuals affected by these conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The trial begins with the administration of the study medication. Participants receive either dupilumab or a placebo that matches dupilumab. The medication is given as a subcutaneous injection, which means it is injected under the skin.
The dosage for dupilumab is 300 mg per injection. The frequency and duration of administration are determined by the study protocol, which typically involves regular intervals over a specified period.
Step 2
Part a: initial assessment
During Part A, the focus is on determining the effect of dupilumab compared to placebo after 24 weeks of treatment. This is assessed through specific measures that examine the condition of the stomach lining.
Participants undergo regular assessments to monitor the treatment's impact on their condition.
Step 3
Part b: efficacy evaluation
Part B aims to demonstrate the effectiveness of dupilumab compared to placebo after another 24 weeks of treatment. This involves both histological (tissue-based) and clinical (symptom-based) evaluations.
Participants continue to receive the study medication and undergo assessments to evaluate changes in their symptoms and tissue condition.
Step 4
Part c: long-term safety and efficacy
Part C extends the treatment period to up to 52 weeks to further assess the safety and effectiveness of dupilumab. This part includes ongoing evaluations similar to those in Parts A and B.
Participants continue to receive the study medication and are monitored for any changes in their condition or any side effects.
Step 5
End of study assessments
At the conclusion of the study, participants undergo final assessments to evaluate the overall impact of the treatment on their condition.
These assessments help determine the long-term benefits and any potential risks associated with the treatment.

Who can join the trial?

6 criteria

Must be a male or female who is at least 12 years old. Adolescents can only join in certain countries if allowed by local rules.
Must have a documented endoscopic biopsy, which is a small tissue sample taken with a special camera tool, showing a diagnosis of Eosinophilic Gastritis (EoG) at least 3 months before the screening.
Must have a baseline endoscopic biopsy showing eosinophilic infiltration, which means a type of white blood cell is present in the stomach lining, confirming EoG.
Must have completed at least 11 out of 14 days of data entry in an electronic diary about EoG or EoD symptoms in the 2 weeks before the first visit.
Must have a history of at least 2 episodes of EoG symptoms per week in the 8 weeks before screening, as reported by the patient.
For the 2 weeks before the first visit, must have an average total symptom score of at least 20, calculated using data from the electronic diary, and an average severity score of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms.

Who cannot join the trial?

10 criteria

Patients who have other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to medications.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have a history of drug or alcohol abuse.
Patients who have certain infections that could affect the study results.
Patients who are taking medications that might interfere with the study treatment.
Patients who have a condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

Dupilumab is a medication being studied for its effectiveness and safety in treating adults and adolescents with Eosinophilic Gastritis, with or without Eosinophilic Duodenitis. The trial aims to see how well this medication works in reducing the symptoms and improving the condition of the stomach and intestines over a period of 24 to 52 weeks. The study will also look at the safety of using Dupilumab for this condition.

Dupilumab

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating eosinophilic gastritis, with or without eosinophilic duodenitis. The main therapeutic indication for dupilumab in this context is to reduce inflammation and symptoms associated with these conditions. At the molecular level, dupilumab works by blocking the signaling of certain proteins involved in the inflammatory response, specifically interleukin-4 and interleukin-13. It is classified as a monoclonal antibody, which is a type of biologic medication designed to target specific pathways in the immune system.

Investigated diseases

Eosinophilic Gastritis – Eosinophilic gastritis is a condition characterized by an increased number of eosinophils, a type of white blood cell, in the stomach lining. This accumulation can lead to inflammation and damage to the stomach tissue. Symptoms may include abdominal pain, nausea, vomiting, and diarrhea. The condition can vary in severity and may be associated with other allergic diseases. It can occur with or without eosinophilic duodenitis, which affects the duodenum, the first part of the small intestine. The progression of the disease involves ongoing inflammation, which can lead to further gastrointestinal symptoms and discomfort.