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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06750289

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ICS-LABA (combination product), benralizumab (combination product), Placebo for Benralizumab (combination product)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
ICS-LABA — combination product: ICS-LABA inhalation · benralizumab — combination product: Benralizumab. · Placebo for Benralizumab — combination product: Placebo for Benralizumab (aka, "placebo").
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether benralizumab 30 mg, given by injection under the skin, helps people aged 12 to 75 with uncontrolled eosinophilic asthma (a type of asthma linked to high levels of a white blood cell called eosinophils). It compares adding benralizumab to usual treatment with the standard approach of increasing the asthma inhaler dose. The study is funded by AstraZeneca.

Who can take part

  • Aged 12 to 75, with written informed consent
  • Doctor-diagnosed asthma treated with a medium-dose inhaled corticosteroid (ICS) plus a long-acting bronchodilator (LABA) inhaler for at least 12 months, and on this treatment for at least 3 months before joining
  • Weigh at least 35 kg
  • Lung function (FEV1, a breathing test) at or below 90% of the predicted level before using an inhaler
  • At least 2 asthma flare-ups in the past 12 months
  • Asthma symptom score (ACQ-6) of 1.5 or higher showing asthma is not well controlled
  • Blood test showing eosinophil count of 150 cells/μL or higher
  • Evidence of variable lung function as defined in the study plan
  • Took at least 70% of their usual asthma inhaler during the run-in period, based on a daily diary

Who may not be able to

  • Another lung condition besides asthma, or any other condition that raises eosinophil levels
  • An asthma flare-up needing steroid tablets, or a chest or airway infection needing antibiotics or antiviral medicine, in the 30 days before joining or during screening
  • Any unstable health problem that could affect taking part
  • Long-term or ongoing infections needing treatment
  • Taking part in another clinical trial or a post-authorisation safety study
  • Alcohol or drug misuse in the past 12 months
  • Current smokers, or former smokers with a history of 10 or more pack-years (former smokers must have quit at least 6 months before joining)

What taking part involves

  • • Benralizumab 30 mg given as an injection under the skin, added to your current medium-dose asthma inhaler
  • • The comparison group has their usual treatment increased to a high-dose inhaled corticosteroid (ICS) plus long-acting bronchodilator (LABA) inhaler
  • • Regular study visits, breathing tests and blood tests as set out in the study plan — details not stated, ask the trial team

Time commitment: Not stated — ask the trial team (a run-in period with a daily asthma diary is mentioned, but the number of visits and total study length are not stated).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
12 Years to 75 Years
Who
All
Number of participants
400
Started
2025-03-28
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for eosinophilic asthma
  • • Phase3 - 400 participants
  • • 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

Who can take part?

  • • Ages 12 Years to 75 Years
  • • Diagnosed with eosinophilic asthma

Where?

  • • Belfast - Research Site
  • • Birmingham - Research Site
  • • Bradford - Research Site
  • • Bristol - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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).

Eosinophilic Asthma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Written agreement to take part
  • ✓Participant must be 12 to 75 years of age
  • ✓Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional...
  • ✓Weight of ≥ 35 kg.
  • ✓Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted

Who cannot take part

  • ✗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 agreement to take part is obtained.
  • ✗Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at...
See the full 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.

Where Is This Study? (9 UK sites)

Research Site

Belfast BT9 7AB, United Kingdom

Recruiting

Research Site

Birmingham B9 5SS, United Kingdom

Recruiting

Research Site

Bradford BD9 6RJ, United Kingdom

Recruiting

Research Site

Bristol BS10 5NB, United Kingdom

Recruiting

Research Site

Chorley PR7 1PP, United Kingdom

Recruiting

Research Site

Leeds LS9 7TF, United Kingdom

Recruiting

Research Site

Liverpool L7 8XP, United Kingdom

NOT_YET_RECRUITING

Research Site

Nottingham NG7 2UH, United Kingdom

WITHDRAWN

Research Site

Portsmouth PO6 3LY, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05