Mepolizumab for Hypereosinophilic Syndrome
(SPHERE Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Children and teens aged 6-17 with hypereosinophilic syndrome (HES) for at least 6 months, having a high eosinophil count, stable on current HES therapy, and who've had two or more HES flares in the past year can join. Those with certain infections, cancer history within a year, non-responsive to steroids, prior mepolizumab use or other monoclonal antibodies recently cannot participate.

Inclusion Criteria

Signed written informed consent

I am either male or female.

I have been diagnosed with HES for at least 6 months.

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Exclusion Criteria

I have not had serious infections or been on infection treatment in the last 4 weeks.

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

My previous cancer has been in remission for less than a year.

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Treatment Details

Interventions

Mepolizumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing the effectiveness and safety of mepolizumab when added to standard care for young patients with HES. It aims to see if this treatment helps reduce symptoms and manage the condition better than standard treatments alone.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants receiving mepolizumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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