Targeted Disease(s):
Non-Cystic Fibrosis Bronchiectasis
Purpose of Study:
This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, 52 week Phase III study 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 52-week double-blind treatment period on investigational product (IP) may be eligible to continue into an open-label extension (OLE), during which all patients will receive benralizumab.The OLE treatment period is intended to allow patients at least one year of treatment with open label benralizumab.
Study Dates:
July 21, 2021 - June 10, 2021
Type of Study:
Pre-Market
Study Design:
Controlled Design
Study Location:
Nationwide
Funding Source:
AstraZeneca
Contact:
Name: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: information.center@astrazeneca.com
ClinicalTrails.gov Identifier:
NCT05006573
Contacts:
Name: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: information.center@astrazeneca.com
Sponsor:
AstraZeneca
Trial URL:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/View?id=26429