Study of Mepolizumab Autoinjector in Asthmatics
Public ClinicalTrials.gov record NCT03099096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of an Autoinjector for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 204959)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03099096
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 3, 2017
- Primary completion
- Nov 29, 2017
- Completion
- Nov 29, 2017
- Last update posted
- Jun 27, 2023
2017
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35243 | — |
| GSK Investigational Site | Scottsdale | Arizona | 85251 | — |
| GSK Investigational Site | Los Angeles | California | 90025 | — |
| GSK Investigational Site | San Diego | California | 92123 | — |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | — |
| GSK Investigational Site | Aventura | Florida | 33180 | — |
| GSK Investigational Site | Miami | Florida | 33173 | — |
| GSK Investigational Site | Albany | Georgia | 31707 | — |
| GSK Investigational Site | Evansville | Indiana | 47713 | — |
| GSK Investigational Site | Baltimore | Maryland | 21236 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Piscataway | New Jersey | 08854 | — |
| GSK Investigational Site | Rochester | New York | 14642 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03099096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03099096 live on ClinicalTrials.gov.