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NCT05006573 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 3 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT05006573 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 100 participants.
The verdict
NCT05006573, a Phase 3 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab. The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).
Interventions
- BIOLOGICAL Benralizumab
- BIOLOGICAL Placebo to Benralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2024-04-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05006573
The ClinicalTrials.gov registry entry for NCT05006573 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 100 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 is the first listed.
NCT05006573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05006573 about?
NCT05006573 is a clinical study titled "Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis". This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchi...
What is the current status of trial NCT05006573?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2021-07-21. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT05006573?
The interventions under investigation include: Benralizumab (BIOLOGICAL), Placebo to Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05006573?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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