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

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.

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.