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

NCT00274703 | Completed Phase 2

• 1 other identifier: MEE103226
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophagitis, Eosinophilic

Keywords

anti IL-5; oesophagitis; eosinophils; mepolizumab; adults

Outcome Measures

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.

Interventions

mepolizumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Olten, 4600, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 20542323 DERIVED

• 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.

  PMID: 19828470 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Esophagitis

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: December 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)