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NCT03401229 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT03401229 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 413 participants.
The verdict
NCT03401229, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.
Interventions
- BIOLOGICAL Benralizumab 30 mg SC + Mometasone Furoate
- BIOLOGICAL Matching placebo SC + Mometasone Furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03401229
The ClinicalTrials.gov registry entry for NCT03401229 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Benralizumab 30 mg SC + Mometasone Furoate is the first listed.
NCT03401229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03401229 about?
NCT03401229 is a clinical study titled "Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis". The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standar...
What is the current status of trial NCT03401229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2018-01-15. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03401229?
The interventions under investigation include: Benralizumab 30 mg SC + Mometasone Furoate (BIOLOGICAL), Matching placebo SC + Mometasone Furoate (BIOLOGICAL).
Who is sponsoring clinical trial NCT03401229?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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