Study of Eosinophilic Granulomatosis with Polyangiitis and Mepolizumab
Research type
Research Study
Full title
A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.
IRAS ID
140971
Contact name
Andrew Wardlaw
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2012-004385-17
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Eosinophilic Granulomatosis with Polyangiitis (EGPA), also called Churg-Strauss Syndrome is a rare condition characterised by inflammation of small blood vessels (vasculitis). EGPA can lead to multiple organ damage and is often associated with conditions such as asthma and sinusitis. One important feature of EGPA is an increase in the numbers of white blood cells called eosinophils which are thought to be associated with the disease.
This study funded by GlaxoSmithKline, will test how safe and effective a medicine called mepolizumab is at treating EGPA.
Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules found in blood and tissue fluids that help fight infection. Mepolizumab attaches to a naturally occurring body protein called Interleukin 5 (IL-5) and stops it from working. IL-5 controls the life cycle of eosinophils which could have an effect on EGPA.
This study will compare mepolizumab and placebo (a placebo looks like the study medicine but doesn’t contain the actual medicine) in participants with EGPA. Participants will continue taking their normal medication for EGPA throughout the study, including oral corticosteroids which will be gradually reduced in participants whose disease is controlled.
There will be 19 visits to attend during which various blood tests, questionnaires and lung tests will be carried out. There will be a screening period of up to 4 weeks followed by a 52 week treatment period and an 8 week follow up period.
Participants will receive either mepolizumab or placebo as three separate injections, given one after the other, every 4 weeks under the skin of the upper arm, thigh or stomach 13 times during the study. There is a 50% chance of receiving either Mepolizumab or placebo.
Participants who complete this study will have participated in the study for a total of 64 weeks.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0414
Date of REC Opinion
12 Dec 2013
REC opinion
Further Information Favourable Opinion