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Completed

NCT Number: NCT00274703

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

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.

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Key information

Conditions

Oesophagitis, Eosinophilic Digestive System Diseases Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Olten, 4600, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepolizumab

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2006
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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