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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00274703
First received: January 10, 2006
Last updated: May 31, 2012
Last verified: February 2011

January 10, 2006
May 31, 2012
December 2005
Not Provided
1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
  • - Reduction of eosinophils in the oesophagus
  • - Safety and tolerability of mepolizumab
Complete list of historical versions of study NCT00274703 on ClinicalTrials.gov Archive Site
1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.
- Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Oesophagitis, Eosinophilic
  • Eosinophilic Oesophagitis in Adult Patients
Drug: mepolizumab
Other Name: mepolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00274703
MEE103226
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP