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 now · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Asthma

In brief

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.

Key facts

Study ID: NCT06750289
Run by: AstraZeneca
People needed: 400
Starts: 2025-03-28
Expected to finish: 2028-11-03
Last updated by the study team: 2026-05-13

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Research Site — Warwick, Rhode Island, United States (enrolling)
Research Site — Plovdiv, Bulgaria (enrolling)
Research Site — Oklahoma City, Oklahoma, United States (enrolling)
Research Site — DuBois, Pennsylvania, United States (enrolling)
Research Site — Greenville, South Carolina, United States (enrolling)
Research Site — San Antonio, Texas, United States (enrolling)
Research Site — Pasadena, California, United States (enrolling)
Research Site — The Bronx, New York, United States (enrolling)
Research Site — Cape Coral, Florida, United States (enrolling)
Research Site — Inglewood, California, United States (enrolling)
Research Site — Tucson, Arizona, United States (enrolling)
Research Site — Leesburg, Florida, United States (enrolling)
Research Site — Newport Beach, California, United States (enrolling)
Research Site — McKinney, Texas, United States (enrolling)
Research Site — Miami, Florida, United States (enrolling)
Research Site — Orlando, Florida, United States (enrolling)
Research Site — Sun City, Arizona, United States (enrolling)
Research Site — Tampa, Florida, United States (enrolling)
Research Site — Winter Park, Florida, United States (enrolling)
Research Site — Ann Arbor, Michigan, United States (enrolling)
Research Site — Henderson, Nevada, United States (enrolling)
Research Site — Northfield, New Jersey, United States (enrolling)
Research Site — Lauderdale Lakes, Florida, United States (enrolling)
Research Site — New Hyde Park, New York, United States (enrolling)
Research Site — Rousse, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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