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NCT04965636 · ClinicalTrials.gov registry record · Phase 3
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT04965636: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04965636 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04965636, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms (worsening symptoms and/or elevated blood eosinophil level) which resulted in need for either: an increase from the most recent dose in the maintenance Oral Corticosteroid (OCS) dose (prednisone/prednisolone equivalent) by at least 10 mg per day for 5 days or an increase in or addition of any immunosuppressive and/or cytotoxic HES therapy from/to the most recent dos
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2025-10-28 |
| Phase | Phase 3 |
What the finished NCT04965636 record still lists
NCT04965636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepolizumab is the first listed.
NCT04965636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04965636 about?
NCT04965636 is a clinical study titled "Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)". 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.
What is the current status of trial NCT04965636?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2022-07-14. Estimated completion is 2025-10-28.
What interventions are being tested in trial NCT04965636?
The interventions under investigation include: Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT04965636?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04965636's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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