Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Condition(s) studied
Investigational drug(s) / intervention(s)
Benralizumab: Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Placebo: Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Study summary
The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.
Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.
Patients who complete treatment will enter 4 weeks follow-up period.
Eligibility
Primary outcome measure(s)
- The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies — From baseline to Week 48 (Visit 10)
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies - The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging — From baseline to Week 48 (Visit 10)
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | |
| Research Site | Los Angeles | California | |
| Research Site | Jacksonville | Florida | |
| Research Site | Miami | Florida | |
| Research Site | Snellville | Georgia | |
| Research Site | Indianapolis | Indiana | |
| Research Site | Iowa City | Iowa | |
| Research Site | Kansas City | Kansas | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Bloomfield Hills | Michigan | |
| Research Site | Rochester | Minnesota | |
| Research Site | St Louis | Missouri | |
| Research Site | Maspeth | New York | |
| Research Site | New Bern | North Carolina | |
| Research Site | Winston-Salem | North Carolina | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Galveston | Texas | |
| Research Site | Lewisville | Texas | |
| Research Site | Mansfield | Texas | |
| Research Site | Calgary | Alberta | |
| Research Site | Aalborg | Denmark | |
| Research Site | Aarhus N | Denmark | |
| Research Site | Copenhagen | Denmark | |
| Research Site | Hvidovre | Denmark | |
| Research Site | Næstved | Denmark | |
| Research Site | Odense C | Denmark | |
| Research Site | Vejle | Denmark | |
| Research Site | Gothenburg | Sweden | |
| Research Site | Lund | Sweden | |
| Research Site | Cambridge | United Kingdom | |
| Research Site | Headington | United Kingdom | |
| Research Site | Leicester | United Kingdom | |
| Research Site | Liverpool | United Kingdom | |
| Research Site | London | United Kingdom | |
| Research Site | Wythenshawe | United Kingdom |
On this site
📄 Fasenra (benralizumab) drug profile →More AstraZeneca trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03953300 on ClinicalTrials.gov ↗ ← All trials in Denmark