A Phase 3, 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

CompletadoFase 3ClinicalTrials.gov

ID: NCT04965636Tipo: INTERVENTIONALInicio: 11 de jul de 2022Fin estimado: 28 de oct de 2025

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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 with documented history of any clinically significant cardiac damage prior to Screening (Visit 1) that, in the opinion of the investigator, would impact the participant's participation during the study
Participants with a history of or current lymphoma, Participants with current malignancy or previous history of cancer in remission for less than 12 months prior to Screening (Visit 1)
Participants who are not responsive to OCS based on clinical response or blood eosinophil counts.
Participants who have previously received mepolizumab in the 4 months prior to enrolment (Visit 2)
Participants receiving non-oral systemic corticosteroids in the 4-week period prior to enrolment (Visit 2).
Participants who have received any other monoclonal antibodies within 30 days or 5 half-lives, whichever is longer, of enrolment (Visit 2).
Participants who have received treatment with an investigational agent (biologic or non-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 received limited, accelerated, or full authorization/approval, and are only in use as part of a clinical trial.
Participants who are currently participating in any other interventional clinical study
Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab).
Evidence of clinically significant abnormality in the hematological, biochemical, or urinalysis screen from the sample collected at Screening (Visit 1), that could put the participant's safety at risk by participating in the study, as judged by the investigator

Intervenciones

drug

Mepolizumab

Mepolizumab will be provided in pre-filled safety syringe

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Quilmes, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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