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Study on the Effects of EP-104IAR and Tetracosactide for Adults with Eosinophilic Esophagitis

Verified siteRegistered drugNo 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 a condition called eosinophilic esophagitis, often abbreviated as EoE. EoE is a disease where a type of white blood cell, called eosinophils, builds up in the esophagus, which can lead to inflammation and difficulty swallowing. The trial is testing a treatment known as EP-104IAR, which contains the active substance fluticasone propionate. This medication is given as an injection and is being evaluated for its safety and how it behaves in the body, as well as its effectiveness in treating EoE.

The purpose of the study is to determine how safe and tolerable EP-104IAR is for adults with EoE, and to understand how the body processes the medication. Participants in the study will receive injections of EP-104IAR and will be monitored over a period of time to observe any changes in their condition and to check for any side effects. The study will also involve regular check-ups to measure the levels of the medication in the blood and to assess the overall health of the participants.

Throughout the study, participants will have their symptoms and health monitored at various intervals, including weeks 2, 4, 8, 12, 24, and up to week 52 for some. This will help researchers understand the impact of the treatment on EoE symptoms, such as difficulty swallowing, and to see if there are any improvements in the condition of the esophagus. The trial aims to provide valuable information on the potential benefits and risks of using EP-104IAR for treating 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
Initial assessment
Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A pregnancy test is required for women of childbearing potential. Participants must agree to use effective birth control methods during the study.
Step 2
Baseline measurements
Baseline measurements are taken, including the Straumann Dysphagia Index (SDI) score and morning serum cortisol levels.
Blood samples are collected to measure plasma concentrations of fluticasone propionate (FP).
Step 3
Treatment administration
The treatment involves the administration of EP-104IAR, which contains tetracosactide and fluticasone propionate.
The medication is given as a suspension for injection. The dosage and frequency are determined based on the study protocol.
Step 4
Follow-up visits
Follow-up visits are scheduled at Weeks 2, 4, 8, 12, 24, 36, and 52. These visits include physical examinations and laboratory tests.
Changes in clinical safety laboratory measurements and vital signs are monitored. Plasma concentrations of FP are measured at specified intervals.
Step 5
Evaluation of treatment effects
The primary focus is on the frequency and severity of any adverse events that may occur during the treatment.
Secondary evaluations include changes in the SDI score, dysphagia, odynophagia, and histological response in the esophagus.
Step 6
End of study
The study is estimated to conclude by March 2026. Final assessments are conducted to evaluate the overall safety and efficacy of the treatment.
Participants are provided with a summary of their individual results and any necessary follow-up care.

Who can join the trial?

5 criteria

Adults between 18 and 75 years old can participate.
Participants must have symptoms of **Eosinophilic Esophagitis (EoE)**, which is a condition affecting the esophagus. This includes having a **Symptom Dysphagia Index (SDI)** score of 5 or more at the start of the study and a confirmed past diagnosis of EoE with more than 15 **eosinophils** per high power field (a measure used in lab tests).
Women who can have children must have a negative pregnancy test at the start and agree to use a highly effective birth control method during the study.
Participants must be willing and able to follow the study procedures and visit schedule.
Participants must be willing and able to give informed consent, which means they understand the study and agree to take part.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse.
Patients who have certain infections that could affect the study.
Patients with a history of certain types of cancer.
Patients who are taking medications that might interfere with the study drug.
Patients with a history of severe allergic reactions.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

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Investigated drugs

EP-104IAR is a medication being studied for its safety and effectiveness in treating adults with eosinophilic esophagitis, a condition where a type of white blood cell builds up in the esophagus, causing inflammation and difficulty swallowing. This trial aims to understand how the body processes the medication and to find the best dose and treatment schedule.

What is already known about the treatment

EP-104IAR – This medication is administered in an open-label trial setting, focusing on adults with eosinophilic esophagitis. Currently, it is in the early stages of clinical trials, specifically Phase 1b/2a, to evaluate its safety, pharmacokinetics, and efficacy. The main therapeutic indication for EP-104IAR is eosinophilic esophagitis, a condition characterized by inflammation of the esophagus. The mechanism of action at the molecular level is not detailed in the available data, but the trial aims to establish its pharmacokinetic profile. EP-104IAR is classified under investigational drugs, as it is still undergoing clinical evaluation to determine its potential benefits and risks.

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 inflame or injure the esophageal tissue. Over time, this inflammation can lead to difficulty swallowing, food impaction, and esophageal narrowing. Symptoms may include heartburn, chest pain, and regurgitation. The condition can affect both children and adults, and its severity can vary widely among individuals. Regular monitoring and lifestyle adjustments are often necessary to manage the symptoms effectively.