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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02836496 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of participants who experienced \>=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is als
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 |
What the finished NCT02836496 record still lists
NCT02836496 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo matching mepolizumab is the first listed.
NCT02836496 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02836496's enrollment target sits among peer trials
108 1664th of 2000 higher than 335 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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