Benralizumab for Uncontrolled Eosinophilic Asthma

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 Phase 3 Interventional Study
Eosinophilic Asthma
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 taking Medium-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.

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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.

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…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT