Status:
COMPLETED
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Oesophagitis, Eosinophilic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00274703
Start Date
December 1 2005
End Date
March 1 2007
Last Update
December 5 2016
Active Locations (1)
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1
GSK Investigational Site
Olten, Switzerland, 4600