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Benralizumab for Uncontrolled Eosinophilic Asthma

This study is looking at a new way to treat uncontrolled eosinophilic asthma, a type of asthma where certain white blood cells (eosinophils) are elevated. It compares adding benralizumab (a medication given by injection under the skin) to your current medium-dose ICS-LABA (inhaled corticosteroid-long-acting beta-agonist) treatment, versus simply increasing your ICS-LABA to a high dose. Researchers want to see if benralizumab is effective and safe in reducing asthma flare-ups over 48 weeks. You might be able to join if you are 12 to 75 years old, have a history of asthma, and are currently using medium-dose ICS-LABA. The study aims to enroll 400 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blind, active-controlled study, meaning participants are randomly assigned to a treatment group, and neither you nor your doctors will know which treatment you are receiving. It compares benralizumab plus medium-dose ICS-LABA to high-dose ICS-LABA plus a placebo (an inactive substance).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study is to measure asthma exacerbation rates from the start of the study through Week 48.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 12–75InterventionalTreatment
AstraZeneca
~400 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:ICS-LABAbenralizumabPlacebo for Benralizumab

At a glance

Recruiting sites
121 of 160 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized asthma exacerbation rate
Measured over Baseline through Week 48

Conditions

Eosinophilic Asthma

Explore related trials

Asthmatic pulmonary eosinophiliaEosinophil Count

Where it's being run

160 sites across 28 states
China25
Spain20
Germany18
Italy14
Florida11
Bulgaria10
France9
United Kingdom9

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Annualized asthma exacerbation rateBaseline through Week 48

    To assess asthma exacerbation rate.