An Evaluation Of Mepolizumab In Therapy Of Eosinophilic O... | NCT00274703

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

NCT00274703

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Dec 5, 2016Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Oesophagitis, Eosinophilic

Interventions

mepolizumab

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Jan 10, 2006

First Submission Date that Met QC Criteria

Jan 10, 2006

First Posted Date

Jan 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
mepolizumab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab

Secondary Outcomes

Measure	Description	Time Frame
1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Olten		4600	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20542323	Derived	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.
19828470	Derived

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D005759	Gastroenteritis