Ireland
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Completed 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 Switzerland tracker
Phase
Phase 3
Started
2025-03-28
Last updated
2026-10-16

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)

  • Annualized asthma exacerbation rate — Baseline through Week 48
    To assess asthma exacerbation rate.

Trial sites (86)

FacilityCityRegionStatus
Research Site Sun City Arizona
Research Site Tucson Arizona
Research Site Inglewood California
Research Site Newport Beach California
Research Site Pasadena California
Research Site Cape Coral Florida
Research Site Lauderdale Lakes Florida
Research Site Leesburg Florida
Research Site Miami Florida
Research Site Tampa Florida
Research Site Winter Park Florida
Research Site Ann Arbor Michigan
Research Site Henderson Nevada
Research Site Northfield New Jersey
Research Site New Hyde Park New York
Research Site The Bronx New York
Research Site DuBois Pennsylvania
Research Site Warwick Rhode Island
Research Site Greenville South Carolina
Research Site San Antonio Texas
Research Site Plovdiv Bulgaria
Research Site Rousse Bulgaria
Research Site Sofia Bulgaria
Research Site Sofia Bulgaria
Research Site Stara Zagora Bulgaria
Research Site Kamloops British Columbia
Research Site Ajax Ontario
Research Site Toronto Ontario
Research Site Windsor Ontario
Research Site Beijing China
Research Site Beijing China
Research Site Changsha China
Research Site Chongqing China
Research Site Fuzhou China
Research Site Guangzhou China
Research Site Guangzhou China
Research Site Hangzhou China
Research Site Hefei China
Research Site Huizhou China
Research Site Jinan China

+ 46 more sites — see the full list on the official registry below.

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 Switzerland