BRISOTE
Research type
Research Study
Full title
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
IRAS ID
1011040
Contact name
Paul Street
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-515162-13
Clinicaltrials.gov Identifier
Research summary
Brisote is a Phase 3b, randomised, double-blind trial. 50% of participants will receive a placebo instead of benralizumab. The placebo will look like benralizumab but with no active drug in it. Participants will receive trial treatment for up to 48 weeks (W), with the total time the participant may be in the trial being 13 months(M). There will be up to about 400 participants between 12-75 years of age with eosinophilic asthma. Potential participants must already be taking a medium dose of ICS and LABA for at least 3M before joining this trial. They must have uncontrolled asthma, (at least 2 asthma attacks in the previous year and their symptoms regularly interfere with their daily life, even with treatment).
Treatments and Procedures: Approximately 5W of a screening and run-in period. During screening doctors will look at the participants' health and do tests to make sure they can stay in the trial. During the run-in, participants will receive a medium dose of ICS and LABA medication for at least 4 W. Then participants will begin the treatment period by being assigned to 1 of the following groups: Group1: 30 mg of benralizumab once every 4W for 3 doses, then once every 8W + Medium dose of ICS and LABA twice a day. Group2: The placebo once every 4 W for 3 doses, then once every 8W + High dose of ICS and LABA twice a day.
Benralizumab is designed to reduce the number of eosinophils in the blood and help control asthma symptoms. Researchers think that adding benralizumab to a medium dose of ICS and LABA may help control asthma symptoms better than just increasing the ICS dose to a high dose of ICS along with LABA. They want to find out how well benralizumab works on top of a medium dose of ICS with LABA and how safe it is in people with eosinophilic asthma compared to increasing the ICS dose.REC name
HSC REC B
REC reference
24/NI/0154
Date of REC Opinion
3 Feb 2025
REC opinion
Further Information Favourable Opinion