Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis.

ABSTRACT:

Background

EsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO-101) is under investigation for the treatment of eosinophilic oesophagitis (EoE).

Aims

To evaluate the efficacy, safety and tolerability of ESO-101 in patients with active EoE.

Methods

We conducted a randomised, placebo-controlled, phase 2, proof-of-concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures.

Results

Treatment with ESO-101 resulted in

SUBMITTER: Lucendo AJ 

PROVIDER: S-EPMC11707640 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature