Last updated: 04/02/2025 05:00:10
Study in Pediatrics with HypEREosinophilic syndrome (SPHERE)SPHERE
GSK study ID
215360
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of HES flares experienced by participants per year
Timeframe: Up to Week 52
Secondary outcomes:
Change in mean daily oral corticosteroids (OCS) dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52
Timeframe: Weeks 0 to 4 and Weeks 48 to 52
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
Timeframe: Weeks 0 to 4 and Weeks 48 to 52
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
Timeframe: Weeks 48 to 52
Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during Weeks 48 to 52
Timeframe: Weeks 48 to 52
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
Timeframe: Baseline and up to Week 52
Number of participants with Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Timeframe: Up to Week 52
Ratio to Baseline in absolute blood eosinophil count
Timeframe: Baseline and up to Week 52
Mepolizumab plasma concentrations
Timeframe: Week 4 and up to Week 52
Interventions:
Enrollment:
16
Primary completion date:
2025-09-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypereosinophilic Syndrome
Product
mepolizumab
Collaborators
NA
Study date(s)
July 2022 to October 2025
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 17 Years
Accepts healthy volunteers
No
- 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).
- Life-threatening HES or life-threatening HES co-morbidities
- Other concurrent medical conditions that may affect the participant’s safety
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Charleston, SC, United States, 29425
Status
Recruitment Complete
Location
GSK Investigational Site
Cleveland, OH, United States, 44106
Status
Recruitment Complete
Location
GSK Investigational Site
Buenos Aires, Argentina, C1028AAP
Status
Recruitment Complete
Location
GSK Investigational Site
Cincinatti, OH, United States, 45229
Status
Recruitment Complete
Location
GSK Investigational Site
Rochester, MN, United States, 55905
Status
Recruitment Complete
Showing 1 - 6 of 13 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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