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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for people aged 12 to 75 with eosinophilic asthma that is not well controlled. Participants will receive an additional therapy called benralizumab while continuing their current asthma medication.
Are You a Good Fit for This Trial?
Must be takingMedium-dose ICSLABA
You may be able to join if
I am between 12 and 75 years old.
I have been diagnosed with asthma for at least 12 months.
I have been using medium-dose ICS and LABA for at least 3 months.
I weigh at least 35 kg.
My lung function test shows a score of 90% or less.
I have had at least 2 asthma attacks in the past year.
I have an ACQ-6 score of 1.5 or higher.
My blood eosinophil count is 150 cells/μL or higher.
You may not be able to join if
I have another serious lung disease other than asthma.
I have had a severe asthma attack needing systemic corticosteroids in the last 30 days.
I have had an infection that required antibiotics or antiviral meds in the last 30 days.
I have an unstable health condition that could affect my participation.
I have a history of drug or alcohol abuse in the last 12 months.
I currently smoke or have smoked a significant amount in the past.
I am taking part in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 mon…
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.
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