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NCT02836496 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT02836496 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 108 participants.
The verdict
NCT02836496, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).
Interventions
- DRUG Placebo matching mepolizumab
- DRUG Mepolizumab 300 mg
- DRUG Active OCS capsules (5 mg prednisolone or prednisone)
- DRUG Placebo matching OCS capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2019-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02836496
The ClinicalTrials.gov registry entry for NCT02836496 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo matching mepolizumab is the first listed.
NCT02836496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02836496 about?
NCT02836496 is a clinical study titled "Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)". Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in associati...
What is the current status of trial NCT02836496?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2017-03-07. Estimated completion is 2019-08-08.
What interventions are being tested in trial NCT02836496?
The interventions under investigation include: Placebo matching mepolizumab (DRUG), Mepolizumab 300 mg (DRUG), Active OCS capsules (5 mg prednisolone or prednisone) (DRUG), Placebo matching OCS capsules (DRUG).
Who is sponsoring clinical trial NCT02836496?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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