Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Study Overview
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Brief Summary
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Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

Detailed Description
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This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).

Official Title
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Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Mesalamine Oral Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Male or female patients, 18 to 75 years of age Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria Negative pregnancy test in females of childbearing potential Exclusion Criteria: Other causes for esophageal eosinophilia Clinical and endoscopic signs of gastroesophageal reflux disease (GERD) Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]) Any known or suspicion for relevant infectious diseases associated with clinical signs, Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile Existing or intended pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesalamine treatment<br>Treatment of patient with mesalamine oral suspension | Drug: Mesalamine Oral Product<br>* Mesalamine oral suspension for oral use<br>* Other names: 5-ASA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with histological remission | Assessment of remission of histological signs of EoE | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with histological response | Assessment of improvement of histological signs of EoE | 4 weeks | 
| Proportion of patients with improvement of symptoms | Clinical symptoms will be assessed via patient reported outcome measures. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal dysfunction, esophageal inflammation