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

GlaxoSmithKline10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Oesophagitis, Eosinophilic

Interventions

mepolizumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Olten, Switzerland

Outcomes

Primary Outcomes

1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab

Secondary Outcomes

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

Data from ClinicalTrials.gov

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