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 range6 Years – 17 Years
SexALL
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…
What they're measuring
1
Number of Participants Who Experienced HES Flares Over the 52-Week Study Treatment Period