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 · NCT06750289 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

ICS-LABAPlacebo for Benralizumabbenralizumab

What this trial is about

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

Age range

12 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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 it is running

60 locations listed across 13 US states.

Research Site - Chandler, Arizona, United States
Research Site - Sun City, Arizona, United States
Research Site - Tucson, Arizona, United States
Research Site - Bakersfield, California, United States
Research Site - Inglewood, California, United States
Research Site - Modesto, California, United States
Research Site - Newport Beach, California, United States
Research Site - Pasadena, California, United States
Research Site - Denver, Colorado, United States
Research Site - Cape Coral, Florida, United States
Research Site - Hialeah, Florida, United States
Research Site - Lauderdale Lakes, Florida, United States
Research Site - Leesburg, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Plantation, Florida, United States
Research Site - Tampa, Florida, United States
Research Site - Winter Park, Florida, United States
Research Site - Ann Arbor, Michigan, United States
Research Site - Henderson, Nevada, United States
Research Site - Northfield, New Jersey, United States
Research Site - Union City, New Jersey, United States
Research Site - New Hyde Park, New York, United States
Research Site - The Bronx, New York, United States
Research Site - Oklahoma City, Oklahoma, United States
Research Site - Oklahoma City, Oklahoma, United States
Research Site - DuBois, Pennsylvania, United States
Research Site - Warwick, Rhode Island, United States
Research Site - Greenville, South Carolina, United States
Research Site - Houston, Texas, United States
Research Site - McKinney, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - Aarau, Switzerland
Research Site - Alcorcón, Spain
Research Site - Alzira (Valencia), Spain
Research Site - Badalona, Spain
Research Site - Ballinasloe, Ireland
Research Site - Barakaldo, Spain
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Bari, Italy
Research Site - Basel, Switzerland
Research Site - Bayonne, France
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Belfast, United Kingdom
Research Site - Bergamo, Italy
Research Site - Berlin, Germany
Research Site - Berlin, Germany
Research Site - Birmingham, United Kingdom
Research Site - Bonn, Germany
Research Site - Bradford, United Kingdom
Research Site - Brescia, Italy
Research Site - Bristol, United Kingdom
Research Site - Burgos, Spain
Research Site - Cagliari, Italy
Research Site - Catanzaro, Italy

Showing 60 of 160 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →