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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 159 participants.
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.
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03099096
The ClinicalTrials.gov registry entry for NCT03099096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 159 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 1 intervention - of which Mepolizumab is the first listed.
NCT03099096 reports 0 study locations.
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.
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