Last updated: 11/04/2018 09:10:35
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
GSK study ID
MEE103226
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- 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
- History of seasonal worsening of EE symptoms or requirement of Esophageal dilation.
- Churg-Strauss Syndrome
Inclusion and exclusion 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)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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