Study in Pediatrics with HypEREosinophilic Syndrome

Overview

Información sobre este estudio

The purpose of this study is to investigate the effectiveness and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Thanai Pongdee, M.D.

Abierto para la inscripción

Contact information:

Kay Bachman R.N., C.C.R.C.

(507) 284-5689

bachman.kay@mayo.edu

More information

Publicaciones

Publications are currently not available