Phase
Condition
N/ATreatment
Mepolizumab
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 toenrolment (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 thefirst dose of mepolizumab (Visit 2)
Male and/or female
Signed written informed consent
Exclusion
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 FactorReceptor (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 dueto viruses, bacteria, and fungi within 4 weeks prior to enrolment (Visit 2)
Participants with a pre-existing parasitic infestation within 6 months prior toenrolment (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 with documented history of any clinically significant cardiac damageprior to Screening (Visit 1) that, in the opinion of the investigator, would impactthe participant's participation during the study
Participants with a history of or current lymphoma, Participants with currentmalignancy or previous history of cancer in remission for less than 12 months priorto Screening (Visit 1)
Participants who are not responsive to OCS based on clinical response or bloodeosinophil counts.
Participants who have previously received mepolizumab in the 4 months prior toenrolment (Visit 2)
Participants receiving non-oral systemic corticosteroids in the 4-week period priorto enrolment (Visit 2).
Participants who have received any other monoclonal antibodies within 30 days or 5half-lives, whichever is longer, of enrolment (Visit 2).
Participants who have received treatment with an investigational agent (biologic ornon-biologic) within the past 30 days or 5 drug half-lives, whichever is longer,prior to enrolment (Visit 2).
Use of candidate Coronavirus disease 2019 (COVID-19) vaccines that have not receivedlimited, accelerated, or full authorization/approval, and are only in use as part ofa clinical trial.
Participants who are currently participating in any other interventional clinicalstudy
Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab).
Evidence of clinically significant abnormality in the hematological, biochemical, orurinalysis screen from the sample collected at Screening (Visit 1), that could putthe participant's safety at risk by participating in the study, as judged by theinvestigator
Study Design
Connect with a study center
GSK Investigational Site
Caba, Buenos Aires C1028AAP
ArgentinaSite Not Available
GSK Investigational Site
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
GSK Investigational Site
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
GSK Investigational Site
Florida, Buenos Aires 1602
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1028AAP
ArgentinaSite Not Available
GSK Investigational Site
Quilmes, 1878
ArgentinaSite Not Available
GSK Investigational Site
Sao Paulo, 05410-002
BrazilSite Not Available
GSK Investigational Site
Sorocaba, 18040-425
BrazilSite Not Available
GSK Investigational Site
Petach Tikva, 49202
IsraelSite Not Available
GSK Investigational Site
Monterrey, Nuevo León 64060
MexicoSite Not Available
GSK Investigational Site
Rotterdam, 3015 CE
NetherlandsSite Not Available
GSK Investigational Site
Madrid, 28009
SpainSite Not Available
GSK Investigational Site
Ankara, 6230
TurkeySite Not Available
GSK Investigational Site
Izmir, 35100
TurkeySite Not Available
GSK Investigational Site
Kayseri, 38039
TurkeySite Not Available
GSK Investigational Site
London, SE5 9RS
United KingdomSite Not Available
GSK Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45229
United StatesSite Not Available
GSK Investigational Site
Cleveland, Ohio 44106
United StatesSite Not Available
GSK Investigational Site
Charleston, South Carolina 29425
United StatesSite Not Available
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