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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: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03401229 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in total nasal polyps score (NPS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The total NPS was the sum of the right and left nostril scores and maximum total NPS is 8, as evaluated by nasal endoscopy and the left and right score were based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected afte
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 |
What the finished NCT03401229 record still lists
NCT03401229 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Benralizumab 30 mg SC + Mometasone Furoate is the first listed.
NCT03401229 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03401229's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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