SPHERE
Research type
Research Study
Full title
A 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.
IRAS ID
1004142
Contact name
Amanda Foster
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-000933-15
Clinicaltrials.gov Identifier
Research summary
This research study is being done to learn more about your hypereosinophilic syndrome (HES) and if the study medicine (mepolizumab) can improve your condition. HES is a disease in which the body produces too many eosinophils (a type of white blood cell).
Mepolizumab, a study drug, is a type of medicine called a monoclonal antibody that is made in the laboratory; it works by blocking a specific protein in the body called interleukin-5. Mepolizumab has been shown to reduce the eosinophil level in the blood in some patients with a high eosinophil level including HES. This study will look at how people with HES react to and how the body uses mepolizumab.
• Some parts of this study are research which means they have not been fully tested yet.
• The research parts of the study are determining whether the study medicine is safe and effective in children and adolescents. Mepolizumab has been approved in the United States and Brazil for adolescents over 12 years of age with HES but is not yet approved for use in children under 12 years of age with HES.
This study will include about 25 participants; of these, at least 5 children will be aged 6 to 11 years and at least 10 adolescents will be aged 12 to 17 years. The study will last for about 64 weeks (approximately 1 year and 3 months). All participants will be taking the same medicine during the study as well as their usual medications. The starting dose of study medicine will be based on your age and weight at the screening visit (Visit 1).REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0350
Date of REC Opinion
10 Feb 2022
REC opinion
Further Information Favourable Opinion