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NCT03021304 · ClinicalTrials.gov registry record · Phase 3
Study of Mepolizumab Safety Syringe in Asthmatics
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT03021304 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 56 participants.
The verdict
NCT03021304, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (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 55 Subjects will be enrolled in the study.
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2017-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03021304
The ClinicalTrials.gov registry entry for NCT03021304 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 56 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.
NCT03021304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03021304 about?
NCT03021304 is a clinical study titled "Study of Mepolizumab Safety Syringe in Asthmatics". This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (100 milligrams \[mg\]) ad...
What is the current status of trial NCT03021304?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2017-02-01. Estimated completion is 2017-08-08.
What interventions are being tested in trial NCT03021304?
The interventions under investigation include: Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT03021304?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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