CWoW - The effect of Benralizumab in Severe Eosinophilic Asthmatics (Chinook)
Research type
Research Study
Full title
A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics (CHINOOK)
IRAS ID
264652
Contact name
Agathe Cabarrot
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-003391-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 20 days
Research summary
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to investigate the effect of treatment with benralizumab on features of airway remodelling, airway physiology and airway inflammation in adult subjects with severe eosinophilic asthma.
Benralizumab is an afucosylated monoclonal antibody that targets interleukin (IL)-5 receptor alpha (IL-5Rα) which is selectively expressed on eosinophils and basophils and depletes eosinophils and basophils by antibody-dependent cellular cytotoxicity (ADCC). In Phase 3 trials in subjects with severe asthma, benralizumab significantly reduced annual exacerbation rate, improved lung function and symptoms compared to placebo.
CHINOOK study is a mechanistic study investigating the effects of Benralizumab on airway tissue eosinophil depletion and airway wall remodelling by assessing macroscopic and morphological changes of the bronchial wall via histological and immunohistochemical assessments of endobronchial biopsies and quantitative CT. Finally, the association between changes in airway wall structure and lung physiology measures will also be investigated through comprehensive lung function testing including spirometry, whole body plethysmography and airway oscillometry.
Prior to enrolment subjects will have been treated with a background asthma therapy of medium- to high-dose inhaled corticosteroids (ICS) plus long-acting β2-agonist (LABA) with or without additional controller medication for at least 12 months and will have persistent symptoms despite documented background therapy of high-dose ICS plus LABA with or without additional controller medication for at least 3 months prior to Visit 1. The study will consist of a screening/run-in period of up to 6 weeks, a treatment period of 48 weeks and a post-treatment follow-up period of 4 weeks. The 48-week treatment period will evaluate the effect of treatment with benralizumab (30 mg) compared to placebo administered subcutaneously every 4 weeks for the first three doses and every 8 weeks thereafter on the primary, secondary, safety and exploratory endpoints of the study.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0357
Date of REC Opinion
9 Aug 2019
REC opinion
Further Information Favourable Opinion