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NCT02417961 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
A Phase 3 study of Asthma, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 162
- Enrollment target
- 20
- Study locations
NCT02417961: Completed Phase 3 study of Asthma, sponsored by AstraZeneca.
NCT02417961 is a Phase 3 study of Asthma that has completed, run by AstraZeneca. The registered enrollment target is 162 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02417961, a Phase 3 study of Asthma, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 162 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.
Primary Outcome
Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection
Conditions Studied
Interventions
- BIOLOGICAL Benralizumab
Study Locations (20)
Florida
- Research Site - Celebration
- Research Site - Ocala
- Research Site - Orlando
- Research Site - Winter Park
Ontario
- Research Site - Ajax
- Research Site - Burlington
- Research Site - Mississauga
- Research Site - Toronto
California
- Research Site - Fountain Valley
- Research Site - Walnut Creek
Quebec
- Research Site - Montreal
- Research Site - Pointe-Claire
Georgia
- Research Site - Albany
Minnesota
- Research Site - Minneapolis
Missouri
- Research Site - St Louis
Nebraska
- Research Site - Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2015-04-27 |
| Est. Completion | 2016-03-14 |
| Phase | Phase 3 |
What the finished NCT02417961 record still lists
NCT02417961 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Benralizumab is the first listed.
NCT02417961 names 20 study sites across 12 states, led by Florida, Ontario, California.
Frequently Asked Questions
What is clinical trial NCT02417961 about?
NCT02417961 is a clinical study titled "Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home". The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab...
What is the current status of trial NCT02417961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 162 participants. The study started on 2015-04-27. Estimated completion is 2016-03-14.
What conditions does trial NCT02417961 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02417961?
The interventions under investigation include: Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02417961?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02417961 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02417961's enrollment target sits among peer trials
162 180th of 374 higher than 195 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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