Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488405
• Other study ID #: SAV-1/EEA
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: September 2023
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 20, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Mesalamine Oral Product
Mesalamine oral suspension for oral use

Locations

Country	Name	City	State
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with histological remission	Assessment of remission of histological signs of EoE	4 weeks
Secondary	Proportion of patients with histological response	Assessment of improvement of histological signs of EoE	4 weeks
Secondary	Proportion of patients with improvement of symptoms	Clinical symptoms will be assessed via patient reported outcome measures.	4 weeks