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
Placebo for Benralizumab: Placebo for Benralizumab (aka, "placebo"). SC injection.
Study summary
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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Annualized asthma exacerbation rate — Baseline through Week 48 To assess asthma exacerbation rate.
Trial sites (160)
Facility
City
Region
Status
Research Site
Chandler
Arizona
Withdrawn
Research Site
Sun City
Arizona
Recruiting
Research Site
Tucson
Arizona
Recruiting
Research Site
Bakersfield
California
Not Yet Recruiting
Research Site
Inglewood
California
Recruiting
Research Site
Modesto
California
Not Yet Recruiting
Research Site
Newport Beach
California
Recruiting
Research Site
Pasadena
California
Recruiting
Research Site
Denver
Colorado
Withdrawn
Research Site
Cape Coral
Florida
Recruiting
Research Site
Hialeah
Florida
Not Yet Recruiting
Research Site
Lauderdale Lakes
Florida
Recruiting
Research Site
Leesburg
Florida
Recruiting
Research Site
Miami
Florida
Not Yet Recruiting
Research Site
Miami
Florida
Not Yet Recruiting
Research Site
Miami
Florida
Recruiting
Research Site
Orlando
Florida
Recruiting
Research Site
Plantation
Florida
Not Yet Recruiting
Research Site
Tampa
Florida
Recruiting
Research Site
Winter Park
Florida
Recruiting
Research Site
Ann Arbor
Michigan
Recruiting
Research Site
Henderson
Nevada
Recruiting
Research Site
Northfield
New Jersey
Recruiting
Research Site
Union City
New Jersey
Not Yet Recruiting
Research Site
New Hyde Park
New York
Recruiting
Research Site
The Bronx
New York
Recruiting
Research Site
Oklahoma City
Oklahoma
Withdrawn
Research Site
Oklahoma City
Oklahoma
Recruiting
Research Site
DuBois
Pennsylvania
Recruiting
Research Site
Warwick
Rhode Island
Recruiting
Research Site
Greenville
South Carolina
Recruiting
Research Site
Houston
Texas
Not Yet Recruiting
Research Site
McKinney
Texas
Recruiting
Research Site
San Antonio
Texas
Recruiting
Research Site
Dimitrovgrad
Bulgaria
Not Yet Recruiting
Research Site
Haskovo
Bulgaria
Not Yet Recruiting
Research Site
Pleven
Bulgaria
Not Yet Recruiting
Research Site
Plovdiv
Bulgaria
Recruiting
Research Site
Plovdiv
Bulgaria
Not Yet Recruiting
Research Site
Rousse
Bulgaria
Recruiting
+ 120 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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