A trial to learn how well benralizumab works and how safe it is when given in addition to standard asthma treatments in people with eosinophilic asthma

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2024-515162-13-00

Record updated

2026. szeptember 15.

Original description

To evaluate the efficacy and safety of benralizumab in eosinophilic asthma patients uncontrolled on medium-dose ICS-LABA, comparing add-on benralizumab vs escalation therapy with high-dose ICS-LABARead full original descriptionShow less

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

To evaluate the efficacy and safety of benralizumab in eosinophilic asthma patients uncontrolled on medium-dose ICS-LABA, comparing add-on benralizumab vs escalation therapy with high-dose ICS-LABA

Inclusion: Written informed consent; Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol; At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary; Participant must be 18 to 75 years of age; Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1; Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids); Weight of ≥ 35 kg; Pre-BD FEV1 of ≤ 90% predicted; Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent; ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3; Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.

Exclusion: Asthma exacerbation requiring use of SCS, or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period; Concurrent participation in another clinical study with an IP or a post-authorisation safety study; Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible; History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained; Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol; Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator’s discretion; Important pulmonary disease other than asthma at the discretion of the investigator (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome).

EU CTIS 2024-515162-13-00