Efficacy and Safety of Benralizumab with an OLE in NCFB (Mahale)
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)
This is a multicentre, randomised, double-blind (DB), 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
NCFB+Eosinophilic inflammation. The study will be conducted at approximately 105 sites in 17 countries.
There is an unmet medical need for treatments for non-cystic fibrosis bronchiectasis (NCFB).
Emerging evidence suggests that there is a subpopulation of patients with non-cystic fibrosis
bronchiectasis with eosinophilic inflammation (NCFB+EI) who may benefit from treatment with
benralizumab, which would target a key underlying driver of inflammation and may reduce
bronchiectasis exacerbations. The aim of this study is to test whether benralizumab provides benefit in
these patients compared with standard-of-care treatment.
To be eligible, patients must have a diagnosis of NCFB confirmed by computed tomography and a
documented history of ≥ 2 exacerbations within the past year. Patients will be excluded if they have
pulmonary disease other than bronchiectasis (eg, asthma, chronic obstructive pulmonary disease,
Potentially eligible patients will enter a screening period of approximately 2 to 6 weeks. After the
screening period, approximately 420 eligible patients will be randomised in a 1:1 ratio to receive
either benralizumab 30 mg administered by subcutaneous (SC) injection every 4 weeks (Q4W) or
matching placebo. The DB treatment period will last 52 weeks. Patients will be stratified at
randomisation by screening blood eosinophil count (≥ 300/μL and < 300/μL strata in a 2:1 ratio),
country, and current chronic macrolide use (yes, no).
All patients who complete the 52-week DB treatment period on investigational product (IP) may be
eligible to continue into an open-label extension (OLE), during which all patients will receive
benralizumab 30 mg Q4W.
HSC REC A
Date of REC Opinion
22 Feb 2021
Further Information Favourable Opinion