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Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) (SPHERE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04965636
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 7, 2021
First Posted Date  ICMJE July 16, 2021
Last Update Posted Date August 9, 2023
Actual Study Start Date  ICMJE August 24, 2022
Estimated Primary Completion Date September 16, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
Number of HES flares experienced by participants per year [ Time Frame: Up to Week 52 ]
The annualized rate of HES flares will be measured.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • Change in mean daily oral corticosteroids (OCS) dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52 [ Time Frame: Weeks 0 to 4 and Weeks 48 to 52 ]
    Change in mean daily OCS dose (prednisone/prednisolone or equivalent) will be assessed.
  • 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 [ Time Frame: Weeks 0 to 4 and Weeks 48 to 52 ]
    Number of participants with >=50% reduction in mean daily OCS dose (prednisone/prednisolone or equivalent) will be assessed.
  • 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 [ Time Frame: Weeks 48 to 52 ]
    Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg will be assessed.
  • Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during Weeks 48 to 52 [ Time Frame: Weeks 48 to 52 ]
    Participants achieving mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg will be evaluated.
  • 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 [ Time Frame: Baseline and up to 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".
  • Number of participants with Anti-drug antibodies (ADA) and neutralizing antibodies (NAb) [ Time Frame: Up to Week 52 ]
    Participants with ADA and NAb will be evaluated.
  • Ratio to Baseline in absolute blood eosinophil count [ Time Frame: Baseline and up to Week 52 ]
    Blood samples will be collected.
  • Mepolizumab plasma concentrations [ Time Frame: Week 4 and up to Week 52 ]
    Blood samples will be collected for determination of mepolizumab plasma concentration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single arm study
Masking: None (Open Label)
Masking Description:
This is an open-label study
Primary Purpose: Treatment
Condition  ICMJE Hypereosinophilic Syndrome
Intervention  ICMJE Drug: Mepolizumab
Mepolizumab will be provided in pre-filled safety syringe
Study Arms  ICMJE Experimental: Participants receiving mepolizumab
Intervention: Drug: Mepolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2021)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 16, 2024
Estimated Primary Completion Date September 16, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Israel,   Mexico,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04965636
Other Study ID Numbers  ICMJE 215360
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP