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NCT03099096 · ClinicalTrials.gov registry record · Phase 3
Study of Mepolizumab Autoinjector in Asthmatics
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
NCT03099096: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03099096 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 159 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03099096, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
Study Summary
This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves or via caregivers. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in autoinjector (100 milligrams \[mg\]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 158 subjects will be enrolled in the study.
Primary Outcome
Due to differences in the labelling requirements among regulatory authorities around the world, two different labelling approaches were included in this global study: labelling that includes a pictogram plus standard labelling elements, or a standard labelling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, 4, 8, and End of Study Visit. Training on the study treatment, device handling and administration technique was provided by the inve
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 3 |
What the finished NCT03099096 record still lists
NCT03099096 is an interventional study that assigns participants to a tested intervention. The registered 159 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepolizumab is the first listed.
NCT03099096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03099096 about?
NCT03099096 is a clinical study titled "Study of Mepolizumab Autoinjector in Asthmatics". This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves or via caregivers. This Phase III study will be an open-label, single-ar...
What is the current status of trial NCT03099096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2017-05-04. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT03099096?
The interventions under investigation include: Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT03099096?
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 NCT03099096's enrollment target sits among peer trials
159 1501st of 2000 higher than 499 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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