Clinical trial NCT00274703: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oesophagitis, Eosinophilic
Keywords: anti IL-5
oesophagitis
eosinophils
mepolizumab
adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
Secondary outcomes:
measure: 1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.