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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

RecruitingPhase 3

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.

Who can join

Ages 12 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Written informed consent
* Participant must be 12 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 (V) 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-Bronchodilator (BD) Forced expiratory volume in 1 second (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.
* 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.

Exclusion Criteria:

* Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
* Asthma exacerbation requiring use of Systemic corticosteroids (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
* 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)
* Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
* History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
* 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.

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 400 · Started: Mar 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06750289

Locations in the U.S.

ArizonaResearch Site, Sun City
Research Site, Tucson
CaliforniaResearch Site, Bakersfield (Not yet recruiting)
Research Site, Inglewood
Research Site, Modesto (Not yet recruiting)
Research Site, Newport Beach
Research Site, Pasadena
FloridaResearch Site, Cape Coral
Research Site, Hialeah (Not yet recruiting)
Research Site, Lauderdale Lakes
Research Site, Leesburg
Research Site, Miami (Not yet recruiting)
Research Site, Miami (Not yet recruiting)
Research Site, Miami
Research Site, Orlando
Research Site, Plantation (Not yet recruiting)
Research Site, Tampa
Research Site, Winter Park
MichiganResearch Site, Ann Arbor
NevadaResearch Site, Henderson
New JerseyResearch Site, Northfield
Research Site, Union City (Not yet recruiting)
New YorkResearch Site, New Hyde Park
Research Site, The Bronx
OklahomaResearch Site, Oklahoma City
PennsylvaniaResearch Site, DuBois
Rhode IslandResearch Site, Warwick
South CarolinaResearch Site, Greenville
TexasResearch Site, Houston (Not yet recruiting)
Research Site, McKinney
Research Site, San Antonio

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.