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Evaluating Benralizumab for Uncontrolled Eosinophilic Asthma

BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.

Phase 3 Interventional AstraZeneca · NCT06750289

This study is testing if adding a new asthma treatment called benralizumab can help people with uncontrolled eosinophilic asthma feel better compared to just increasing their current medication.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages12 Years to 75 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsbenralizumab
Locations160 sites (Chandler, Arizona and 159 other locations)
Trial IDNCT06750289 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of benralizumab, administered subcutaneously, as an add-on therapy for patients with uncontrolled eosinophilic asthma who are currently on medium-dose inhaled corticosteroids and long-acting beta-agonists. Participants will be randomized to receive either benralizumab or a placebo while continuing their current asthma treatment. The study aims to determine if adding benralizumab is more effective than escalating to high-dose inhaled therapy. The trial is designed as a double-blind, active-controlled, parallel group study conducted globally.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 75 with a documented history of uncontrolled eosinophilic asthma despite medium-dose ICS-LABA treatment.

Not a fit: Patients who are well-controlled on their current asthma medications or those with contraindications to benralizumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide better asthma control for patients who are not adequately managed on their current therapy.

How similar studies have performed: Previous studies have shown promising results with benralizumab in similar patient populations, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 159 other locations

+110 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic AsthmaBenralizumab,FASENRA,Medium-Dose Inhaled Corticosteroid,Long-acting β2-Agonist
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.