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

Launched by ASTRAZENECA · Dec 19, 2024

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ClinConnect Summary

This clinical trial is studying a medication called benralizumab to see how well it works and how safe it is for people with uncontrolled eosinophilic asthma. Eosinophilic asthma is a type of asthma that involves certain white blood cells called eosinophils, which can contribute to asthma symptoms. The trial compares using benralizumab as an additional treatment to the usual method of increasing asthma medication to a higher dose. Participants will be aged between 12 and 75 years, and to join, they need to have been diagnosed with asthma and have been using a medium dose of asthma medication for at least a year, along with experiencing asthma flare-ups in the past year.

If you qualify and choose to participate, you can expect to receive either the new treatment or the standard increased medication. The study aims to better understand how well benralizumab helps manage asthma symptoms and if it improves overall lung function. It's important to note that participants will need to provide consent and meet certain health criteria, such as having specific eosinophil counts in their blood and a history of asthma symptoms despite their current treatment. This trial is currently not recruiting participants, so it will be important to keep an eye out for updates if you or someone you know is interested in participating.

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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 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.