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Clinical Trials in the USA / NCT06750289
Recruiting Phase 3

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

NCT06750289 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-03-28
Last updated
2026-05-13

Condition(s) studied

Eosinophilic Asthma

Investigational drug(s) / intervention(s)

ICS-LABAbenralizumabPlacebo for Benralizumab

ICS-LABA: ICS-LABA inhalation

benralizumab: Benralizumab. SC injection.

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)

Trial sites (160)

FacilityCityRegionStatus
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.

On this site

📄 Fasenra (benralizumab) drug profile →

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT06750289 on ClinicalTrials.gov ↗ ← All trials in the USA