Study of mepolizumab in patients with HES from Study 200622
Research type
Research Study
Full title
A multi-centre, open-label extension, safety study to describe the longterm clinical experience of mepolizumab in participants with hypereosinophilic syndrome (HES) from Study 200622
IRAS ID
231327
Contact name
Andrew Wardlaw
Contact email
Sponsor organisation
GlaxoSmithkline
Eudract number
2017-000184-32
Duration of Study in the UK
1 years, 7 months, 9 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 the blood that help fight infection. Mepolizumab attaches to a naturally occurring body protein called Interleukin 5 (IL-5) and helps to stop 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 is an extension study to describe the long term safety of mepolizumab in participants with HES from Study 200622 (an earlier study looking at mepolizumab in HES). In particular, the study will test how well mepolizumab works in treating HES when used for up to 1 year (up to 32 weeks from the preceding study (Study 200622) and up to 20 weeks from this study, (Study 205203)).
Participants will continue taking their normal medication for their HES throughout the study.
There will be 6 clinic visits during which various blood, lung and heart tests will be carried out as well as questionnaires and physical assessments. There will be a 20 week treatment period and a follow-up visit (12 weeks post-last dose).
Participants aged 12 years and older will receive mepolizumab as three separate injections for each dose, ,given under the skin of the upper arm, thigh or stomach. Doses will be given every 4 weeks, 5 times during the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0367
Date of REC Opinion
10 Nov 2017
REC opinion
Further Information Favourable Opinion