Fasenra 30 mg solution for injection in pre-filled syringe
Sponsors
Astrazeneca AB, AstraZeneca AB, Glaxosmithkline Research & Development Limited, Centre Hospitalier Universitaire De Nantes
Conditions
Eosinophilic AsthmaEosinophilic Granulomatosis with Polyangiitis (EGPA)Hypereosinophilic Syndrome (HES)Paediatric Patients with Severe Eosinophilic Asthma
Asthma is a long-term lung disorder that causes airways
(the tubes that carry air in and out of the lungs) to become
inflamed. Patients with severe asthma are likely to have high
levels of eosinophils in their blood. Eosinophils are a type of
white blood cell that can cause inflammation and can
increase the number of asthma attacks and contribute to the
decline of lung function.Severe CRSwNP patients with asthma.Severe asthmaSevere asthma with an eosinophilic phenotypeSevere eosinophilic asthma
Phase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)
RecruitingCTIS2022-501344-14-00
Start: 2023-06-05Target: 72Updated: 2025-11-26
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-
Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients
with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)
CompletedCTIS2023-507987-38-00
Start: 2021-10-14End: 2024-12-18Target: 79Updated: 2025-02-03
A Randomised, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study).
Active, not recruitingCTIS2023-510248-19-00
Start: 2020-01-21Target: 72Updated: 2025-05-13
A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab
CompletedCTIS2023-510230-84-00
Start: 2021-05-28End: 2025-09-10Target: 750Updated: 2025-10-27
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-Week Phase III Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)
Active, not recruitingCTIS2023-510455-28-00
Start: 2020-06-10Target: 60Updated: 2025-11-06
BRISOTE: A Multicentre, Randomised, Double-blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist
RecruitingCTIS2024-515162-13-00
Start: 2025-04-29Target: 172Updated: 2025-12-16
Phase 4
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)
Active, not recruitingCTIS2023-506614-40-00
Start: 2019-11-11Target: 27Updated: 2025-05-08
Predictive Signature of Benralizumab Response. BENRAPRED Study.
RecruitingCTIS2024-514843-27-00
Start: 2021-10-11Target: 220Updated: 2025-07-24