Clinical Trial

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Study acronym: BRISOTE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
Protocol Amendment History 3 changes
notable Trial sites expanded: 157 -> 160 locations 2026-05-14
notable Primary completion pushed: 2027-11-03 -> 2028-11-03 2026-05-14
minor Completion pushed: 2027-11-03 -> 2028-11-03 2026-05-14
Trial Details
NCT Number NCT06750289
Lead Sponsor AstraZeneca
Conditions Eosinophilic Asthma
Enrollment 400 participants
Start Date 2025-03-28
Primary Completion 2028-11-03 (estimated)
Study Completion 2028-11-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-13