Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)

Hypereosinophilic Syndrome Clinical Trial

— SPHERE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965636
• Other study ID #: 215360
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hypereosinophilic Syndrome
• Syndrome

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