Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05488405

Enrollment

Registered

2022-08-04

Start date

2023-02-09

Completion date

2023-07-20

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

Esophageal dysfunction, esophageal inflammation

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).

Interventions

DRUGMesalamine Oral Product

Mesalamine oral suspension for oral use

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with histological remission	4 weeks	Assessment of remission of histological signs of EoE

Secondary

Measure	Time frame	Description
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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026