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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

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.

Condition or disease Intervention/treatment Phase
Hypereosinophilic Syndrome Drug: Mepolizumab Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
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
Actual Study Start Date : August 24, 2022
Estimated Primary Completion Date : September 16, 2024
Estimated Study Completion Date : September 16, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Mepolizumab

Arm Intervention/treatment
Experimental: Participants receiving mepolizumab Drug: Mepolizumab
Mepolizumab will be provided in pre-filled safety syringe




Primary Outcome Measures :
  1. Number of HES flares experienced by participants per year [ Time Frame: Up to Week 52 ]
    The annualized rate of HES flares will be measured.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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".

  6. 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.

  7. Ratio to Baseline in absolute blood eosinophil count [ Time Frame: Baseline and up to Week 52 ]
    Blood samples will be collected.

  8. Mepolizumab plasma concentrations [ Time Frame: Week 4 and up to Week 52 ]
    Blood samples will be collected for determination of mepolizumab plasma concentration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965636


Contacts
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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

Locations
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United States, Minnesota
GSK Investigational Site Recruiting
Rochester, Minnesota, United States, 55905
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Thanai Pongdee         
United States, Ohio
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Cleveland, Ohio, United States, 44106
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, South Carolina
GSK Investigational Site Recruiting
Charleston, South Carolina, United States, 29425
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Argentina
GSK Investigational Site Recruiting
Caba, Buenos Aires, Argentina, C1028AAP
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pablo Matías Pascale         
GSK Investigational Site Recruiting
Florencio Varela, Buenos Aires, Argentina, 1888
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Florida, Buenos Aires, Argentina, 1602
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Quilmes, Buenos Aires, Argentina, 1878
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Brazil
GSK Investigational Site Recruiting
Sao Paulo, São Paulo, Brazil, 05410-002
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Vicente Odone Filho         
GSK Investigational Site Recruiting
Sorocaba, São Paulo, Brazil, 18040-425
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Israel
GSK Investigational Site Recruiting
Petach Tikva, Israel, 49202
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Mexico
GSK Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 64060
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Spain
GSK Investigational Site Recruiting
Madrid, Spain, 28009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Turkey
GSK Investigational Site Recruiting
Ankara, Turkey, 6230
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sule Unal         
GSK Investigational Site Recruiting
Izmir, Turkey, 35100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yesim Aydinok         
GSK Investigational Site Recruiting
Kayseri, Turkey, 38039
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United Kingdom
GSK Investigational Site Recruiting
London, United Kingdom, SE5 9RS
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04965636    
Other Study ID Numbers: 215360
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Hypereosinophilic Syndrome
Mepolizumab
Safety
Efficacy
Pediatric
Adolescent
Additional relevant MeSH terms:
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Hypereosinophilic Syndrome
Syndrome
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases