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NCT03085797 · ClinicalTrials.gov registry record · Phase 3
Effect of Mepolizumab in Severe Bilateral Nasal Polyps
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 414
- Enrollment target
NCT03085797: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03085797 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 414 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03085797, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 414 participants
- Enrollment target
Study Summary
Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. Mepolizumab (SB240563) is an Immunoglobulin G 1 \[IgG1\], kappa humanized monoclonal antibody (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5) receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue eosinophils and hence is assumed to be a treatment option in a number of eosinophilic diseases including NP. The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an add on to maintenance treatment in adults with severe bilateral NP. The study will include a 4-week run in period followed by randomization to a 52-week treatment period. Participants will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run in + treatment period + follow up), participants will receive a standard of care (SoC) for NP which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal douching, occasional short courses of high dose oral corticosteroids (OCS) and/or antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or placebo. In addition, up to the first 200 randomized participants will be followed up every other month for up to a further 6 months after the Visit 15 (7 months post last dose) in order to assess maintenance of response and to validate a physiological model derive
Interventions
- DRUG Placebo
- DRUG Mepolizumab
- DRUG Mometasone furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2019-12-11 |
| Phase | Phase 3 |
What the finished NCT03085797 record still lists
NCT03085797 is an interventional study that assigns participants to a tested intervention. The registered 414 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 (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03085797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03085797 about?
NCT03085797 is a clinical study titled "Effect of Mepolizumab in Severe Bilateral Nasal Polyps". Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal o...
What is the current status of trial NCT03085797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 414 participants. The study started on 2017-05-25. Estimated completion is 2019-12-11.
What interventions are being tested in trial NCT03085797?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (DRUG), Mometasone furoate (DRUG).
Who is sponsoring clinical trial NCT03085797?
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 NCT03085797's enrollment target sits among peer trials
414 905th of 2000 higher than 1,096 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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