Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) (NCT04965636) | Clinical Trial Compass
CompletedPhase 3
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
Argentina16 participantsStarted 2022-07-14
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be aged 6 to 17 years inclusive, at Screening (Visit 1).
* Participants who have been diagnosed with HES for at least 6 months prior to enrolment (Visit 2).
* A history of 2 or more HES flares within the past 12 months prior to Screening (Visit 1).
* Participants must have blood eosinophil count \>=1000 cells per microliter (/mcL) present at Screening.
* Participants must be on a stable dose of HES therapy for the 4 weeks prior to the first dose of mepolizumab (Visit 2)
* Male and/or female
* Signed written informed consent
Exclusion Criteria:
* Life-threatening HES or life-threatening HES co-morbidities
* Other concurrent medical conditions that may affect the participant's safety
* Eosinophilia of unknown significance
* Fusion tyrosine kinase gene translocation \[FIP1L1- Platelet-derived Growth Factor Receptor (PDGFRα) (F/P)\] positivity
* Clinical diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)
* Participants with chronic or ongoing active infections requiring systemic treatment, as well as participants who have experienced clinically significant infections due to viruses, bacteria, and fungi within 4 weeks prior to enrolment (Visit 2)
* Participants with a pre-existing parasitic infestation within 6 months prior to enrolment (Visit 2)
* Participants with a known immunodeficiency (e.g. Human immunodeficiency virus \[HIV\]), other than that explained by the use of OCS or other therapy taken for HES
* Participants w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced HES Flares Over the 52-Week Study Treatment Period