Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04053634 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 689
- Enrollment target
NCT04053634 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 689 participants.
The verdict
NCT04053634, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 689 participants
- Enrollment target
Study Summary
Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count. The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Benralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 689 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04053634
The ClinicalTrials.gov registry entry for NCT04053634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 689 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 Placebo is the first listed.
NCT04053634 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04053634 about?
NCT04053634 is a clinical study titled "Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations". Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations ...
What is the current status of trial NCT04053634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 689 participants. The study started on 2019-08-26. Estimated completion is 2025-07-28.
What interventions are being tested in trial NCT04053634?
The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04053634?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.