Recruiting
Phase 3

Benralizumab

Sponsor:

AstraZeneca

Code:

NCT06750289

Conditions

Eosinophilic Asthma

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

ICS-LABA

benralizumab

Placebo for Benralizumab

Study Details

Brief 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.

Conditions

Eosinophilic Asthma

Study ID

NCT06750289

Start date

Mar 28, 2025

Status verified date

May, 2026

Completion date

Nov 3, 2028

Anticipated

Primary completion date

Nov 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medium-dose ICS-LABA + benralizumab

Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.

active comparator: High-dose ICS-LABA + placebo

Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.

Interventions

ICS-LABA

ICS-LABA inhalation

benralizumab

Benralizumab. SC injection.

Placebo for Benralizumab

Placebo for Benralizumab (aka, "placebo"). SC injection.

Primary outcome measure

  • Annualized asthma exacerbation rate [ Time Frame: Baseline through Week 48 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Sun City, Arizona, United States, 85351

Research Site

Recruiting

Tucson, Arizona, United States, 85704

Research Site

Recruiting

Inglewood, California, United States, 90301

Research Site

Recruiting

Newport Beach, California, United States, 92663

Research Site

Recruiting

Pasadena, California, United States, 91101

Research Site

Recruiting

Cape Coral, Florida, United States, 33990

Research Site

Recruiting

Lauderdale Lakes, Florida, United States, 33313

Research Site

Recruiting

Leesburg, Florida, United States, 34748

Research Site

Recruiting

Miami, Florida, United States, 33175

Research Site

Recruiting

Orlando, Florida, United States, 32819

Research Site

Recruiting

Tampa, Florida, United States, 33607

Research Site

Recruiting

Winter Park, Florida, United States, 32789

Research Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Research Site

Recruiting

Henderson, Nevada, United States, 89052

Research Site

Recruiting

Northfield, New Jersey, United States, 08225

Research Site

Recruiting

New Hyde Park, New York, United States, 11042

Research Site

Recruiting

The Bronx, New York, United States, 10459

Research Site

Recruiting

Oklahoma City, Oklahoma, United States, 73111

Research Site

Recruiting

DuBois, Pennsylvania, United States, 15801

Research Site

Recruiting

Warwick, Rhode Island, United States, 02886

Research Site

Recruiting

Greenville, South Carolina, United States, 29607

Research Site

Recruiting

McKinney, Texas, United States, 75069

Research Site

Recruiting

San Antonio, Texas, United States, 78251

Research Site

Recruiting

Kamloops, British Columbia, Canada, V2C 5T1

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Research Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Research Site

Recruiting

Toronto, Ontario, Canada, M5T 3A9

Research Site

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Research Site

Recruiting

Québec, Quebec, Canada, G1G 3Y8

Research Site

Recruiting

Sainte-Foy, Quebec, Canada, G1V 4G5

More Information

Sponsor

AstraZeneca

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Eosinophilic Asthma;
  • Benralizumab,
  • FASENRA,
  • Medium-Dose Inhaled Corticosteroid,
  • Long-acting β2-Agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-05-13.