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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04965636
Other study ID # 215360
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 24, 2022
Est. completion date September 16, 2024

Study information

Verified date August 2023
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date September 16, 2024
Est. primary completion date September 16, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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 (PDGFRa) (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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mepolizumab
Mepolizumab will be provided in pre-filled safety syringe

Locations

Country Name City State
Argentina GSK Investigational Site Caba Buenos Aires
Argentina GSK Investigational Site Florencio Varela Buenos Aires
Argentina GSK Investigational Site Florida Buenos Aires
Argentina GSK Investigational Site Quilmes Buenos Aires
Brazil GSK Investigational Site Sao Paulo São Paulo
Brazil GSK Investigational Site Sorocaba São Paulo
Israel GSK Investigational Site Petach Tikva
Mexico GSK Investigational Site Monterrey Nuevo León
Spain GSK Investigational Site Madrid
Turkey GSK Investigational Site Ankara
Turkey GSK Investigational Site Izmir
Turkey GSK Investigational Site Kayseri
United Kingdom GSK Investigational Site London
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Israel,  Mexico,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of HES flares experienced by participants per year The annualized rate of HES flares will be measured. Up to Week 52
Secondary Change in mean daily oral corticosteroids (OCS) dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52 Change in mean daily OCS dose (prednisone/prednisolone or equivalent) will be assessed. Weeks 0 to 4 and Weeks 48 to 52
Secondary Number of participants with >=50 percent (%) reduction in mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 compared with Weeks 48 to 52 Number of participants with >=50% reduction in mean daily OCS dose (prednisone/prednisolone or equivalent) will be assessed. Weeks 0 to 4 and Weeks 48 to 52
Secondary Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 milligrams (mg) during Weeks 48 to 52 in participants that are taking OCS at Baseline Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg will be assessed. Weeks 48 to 52
Secondary Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during Weeks 48 to 52 Participants achieving mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg will be evaluated. Weeks 48 to 52
Secondary Change from Baseline in fatigue severity based on Brief Fatigue Inventory (BFI) Item 3 (worst level of fatigue during past 24 hours) for Week 52 Item 3 of the BFI is a 11-point scale that measures fatigue (weariness, tiredness) ranging from 0 "no fatigue" to 10 "as bad as you can imagine". Baseline and up to Week 52
Secondary Number of participants with Anti-drug antibodies (ADA) and neutralizing antibodies (NAb) Participants with ADA and NAb will be evaluated. Up to Week 52
Secondary Ratio to Baseline in absolute blood eosinophil count Blood samples will be collected. Baseline and up to Week 52
Secondary Mepolizumab plasma concentrations Blood samples will be collected for determination of mepolizumab plasma concentration. Week 4 and up to Week 52
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