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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00274703

Collaborator

(none)

Enrollment

Location

14.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oesophagitis, Eosinophilic	Drug: mepolizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
1. at least one episode of dysphagia per week
c.Inadequate response to routine EE treatment
1. 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.