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

Oesophagitis, Eosinophilic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274703
• Other study ID #: MEE103226
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: December 2, 2016
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: December 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Oesophagitis, Eosinophilic

Intervention

Drug:
• mepolizumab

Locations

Country	Name	City	State
Switzerland	GSK Investigational Site	Olten

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
Secondary	1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.

External Links

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