Study of mepolizumab in patients with HES who receive standard therapy
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of mepolizumab in the treatment of adolescent and adult subjects with severe hypereosinophilic syndrome
IRAS ID
209463
Contact name
Andrew Wardlaw
Contact email
Eudract number
2014-001232-11
Duration of Study in the UK
2 years, 4 months, 14 days
Research summary
Hypereosinophilic syndrome or HES, is a group of rare blood disorders without a known cause in which eosinophils, a type of white blood cell, are overproduced in the body. This can eventually cause damage to various different organs.
This study funded by GlaxoSmithKline, will test how safe and effective a medicine called mepolizumab is at treating and preventing worsening of HES symptoms.
Mepolizumab is a monoclonal antibody. 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 the signs and symptoms of HES.
This study will compare mepolizumab and placebo (a placebo looks like the study medicine but doesn’t contain the actual medicine) in participants with HES. Participants will continue taking their normal medication for their HES throughout the study.
There will be 12 visits to attend during which various blood tests, questionnaires, lung and heart tests will be carried out. There will be a screening period of up to 4 weeks followed by a 32 week treatment period and up to 8 week additional follow up period.
Participants aged 12 years and older 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 8 times during the study. There is a 50% chance of receiving either mepolizumab or placebo.
Participants who complete the 32 week study period (even if they withdraw from the treatment during the study and continue with the visits) will, if eligible, be offered continued treatment with active mepolizumab for their HES.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0422
Date of REC Opinion
16 Nov 2016
REC opinion
Further Information Favourable Opinion