Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Phase 2

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Mesalamine Oral Product

• Registration Number: NCT05488405
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Study Start: 2023-02-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesalamine treatment	Mesalamine Oral Product	Treatment of patient with mesalamine oral suspension

Primary Outcome Measures

Name	Time	Method
Proportion of patients with histological remission	4 weeks	Assessment of remission of histological signs of EoE

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with histological response	4 weeks	Assessment of improvement of histological signs of EoE
Proportion of patients with improvement of symptoms	4 weeks	Clinical symptoms will be assessed via patient reported outcome measures.

Trial Locations

Locations (1)

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland