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Completed

NCT Number: NCT05488405

Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsspital Zürich

Zurich, 8091, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalamine Oral Product

Drug

Mesalamine oral suspension for oral use

Other names: 5-ASA

Primary outcomes

  1. Proportion of patients with histological remission

    Time frame: 4 weeks

    Assessment of remission of histological signs of EoE

Secondary outcomes

  1. Proportion of patients with histological response

    Time frame: 4 weeks

    Assessment of improvement of histological signs of EoE

  2. Proportion of patients with improvement of symptoms

    Time frame: 4 weeks

    Clinical symptoms will be assessed via patient reported outcome measures.

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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