Comparing benralizumab with ICS-LABA for eosinophilic asthma
Official title: 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.
- Phase 3
- 2 groups
- Sites in Edmonton, Kamloops and 6 more cities
- Recruiting
Interventions
- Other intervention
ICS-LABA
ICS-LABA inhalation
- Other intervention
benralizumab
Benralizumab. SC injection.
- Other intervention
Placebo for Benralizumab
Placebo for Benralizumab (aka, "placebo"). SC injection.
Canadian Sites (8)
7 of 8 recruiting
- Recruiting
Research Site
Kamloops, British Columbia
- Recruiting
Research Site
Vancouver, British Columbia
- Recruiting
Research Site
Ajax, Ontario
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Windsor, Ontario
- Recruiting
Research Site
Québec, Quebec
- Recruiting
Research Site
Sainte-Foy, Quebec
- Withdrawn
Research Site
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must be 12 to 75 years of age
- +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 periodRun-in periodA short trial period before the study proper begins.Read more → (from V2 to V3) and at V3.
- +Evidence of asthma as documented by excessive variability in lung function, as defined in the protocolProtocolThe detailed plan a study must follow.Read more →.
- +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
- −Important pulmonary disease other than asthma at the discretion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → is obtained or during the screeningScreeningThe checks done before joining, to see whether a study fits.Read more →/run-in periodRun-in periodA short trial period before the study proper begins.Read more →
- −Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocolProtocolThe detailed plan a study must follow.Read more →.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives ICS-LABA and benralizumab.
Registry label: A: Medium-dose ICS-LABA + benralizumab
Group B, the comparison group, receives ICS-LABA, together with one or more of: PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → for Benralizumab.
Registry label: B: High-dose ICS-LABA + placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 400 people.
The study is currently expected to finish around November 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Week 48.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Annualized asthma exacerbation rate — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Week 48.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06750289 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ICS-LABACombination product
ICS-LABA inhalation
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
About benralizumabCombination product
Benralizumab. SC injection.
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
About Placebo for BenralizumabCombination product
Placebo for Benralizumab (aka, "placebo"). SC injection.
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Week 48.
The study as a whole is currently expected to finish around 2028-11-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Edmonton, Alberta, Canada; Kamloops, British Columbia, Canada; Vancouver, British Columbia, Canada; Ajax, Ontario, Canada; Toronto, Ontario, Canada; Windsor, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Research Site
Ann Arbor, Michigan, United States
Research Site
New Hyde Park, New York, United States
Research Site
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.