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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Oesophagitis, Eosinophilic

Treatments

Drug: mepolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00274703

MEE103226

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.