An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients

A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Provide a Preliminary Evaluation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Intravenous Anti-human Interleukin-5 (Mepolizumab, 750mg and 1500mg) in the Treatment of Eosinophilic Oesophagitis in Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274703

Enrollment

Registered

2006-01-11

Start date

2005-12-31

Completion date

2007-03-31

Last updated

2016-12-05

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

Conditions

Oesophagitis, Eosinophilic

Keywords

anti IL-5, oesophagitis, eosinophils, mepolizumab, adults

Brief summary

Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.

Interventions

DRUGmepolizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Document evidence/presence of Oesophagitis prior to commencing trial drug. * a)Histological evidence of Oesophagitis: greater than 20x eosinophils per high power field (X400) on histology of esophageal mucosal biopsy * b. at least one episode of dysphagia per week * c.Inadequate response to routine EE treatment * D. No other known causes of oesophagitis, or esophageal or generalized eosinophilia * Not pregnant or nursing

Exclusion criteria

* History of seasonal worsening of EE symptoms or requirement of Esophageal dilation. * Churg-Strauss Syndrome * Wegener's Granulomatosis * Lymphoma, hematological malignancy, advanced and metastatic solid tumors * Active H. pylori infection. * Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.

Design outcomes

Primary

Measure	Time frame
1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab	—

Secondary

Measure	Time frame
1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026