Last updated: 11/04/2018 09:10:35

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

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GSK study ID
MEE103226
Clinicaltrials.gov ID
NCT00274703
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: mepolizumab
    • Enrollment:
    10
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Oesophagitis, Eosinophilic
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to March 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Document evidence/presence of Oesophagitis prior to commencing trial drug.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Olten, Switzerland, 4600
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-27-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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