NCT06750289

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

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Conditions

• Eosinophilic Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ICS-LABA	ICS-LABA inhalation
COMBINATION_PRODUCT	benralizumab	Benralizumab. SC injection.
COMBINATION_PRODUCT	Placebo for Benralizumab	Placebo for Benralizumab (aka, "placebo"). SC injection.

Timeline

• Start date: 2025-03-28
• Primary completion: 2027-11-03
• Completion: 2027-11-03
• First posted: 2024-12-27
• Last updated: 2026-03-19

Locations

157 sites across 13 countries: United States, Bulgaria, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Norway, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study