Back to resultsAn Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
Primary Purpose
Oesophagitis, Eosinophilic
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
mepolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Oesophagitis, Eosinophilic focused on measuring anti IL-5, oesophagitis, eosinophils, mepolizumab, adults
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00274703
Brief Title
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophagitis, Eosinophilic
Keywords
anti IL-5, oesophagitis, eosinophils, mepolizumab, adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mepolizumab
Primary Outcome Measure Information:
Title
1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
Secondary Outcome Measure Information:
Title
1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20542323
Citation
Conus S, Straumann A, Bettler E, Simon HU. Mepolizumab does not alter levels of eosinophils, T cells, and mast cells in the duodenal mucosa in eosinophilic esophagitis. J Allergy Clin Immunol. 2010 Jul;126(1):175-7. doi: 10.1016/j.jaci.2010.04.029. Epub 2010 Jun 12. No abstract available. Erratum In: J Allergy Clin Immunol. 2011 Mar;127(3):833.
Results Reference
derived
PubMed Identifier
19828470
Citation
Straumann A, Conus S, Grzonka P, Kita H, Kephart G, Bussmann C, Beglinger C, Smith DA, Patel J, Byrne M, Simon HU. Anti-interleukin-5 antibody treatment (mepolizumab) in active eosinophilic oesophagitis: a randomised, placebo-controlled, double-blind trial. Gut. 2010 Jan;59(1):21-30. doi: 10.1136/gut.2009.178558.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MEE103226
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MEE103226
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MEE103226
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MEE103226
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MEE103226
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
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