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. - BRISOTE

Study identifier:D3250C00101

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2024-515162-13-00

Will Be Recruiting

Official Title

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.

Medical condition

Eosinophilic Asthma

Phase

Phase 3

Healthy volunteers

Study drug

ICS-LABA, benralizumab, Placebo for Benralizumab

Sex

All

Estimated Enrollment

400

Study type

Interventional

Age

12 Years - 75 Years

Date

Study Start Date: 31 Mar 2025

Estimated Primary Completion Date: 29 Oct 2027

Estimated Study Completion Date: 29 Oct 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AstraZeneca

Collaborators

Inclusion and 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 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-BD 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 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.

No locations available

Arms	Assigned Interventions
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.	Combination Product: ICS-LABA ICS-LABA inhalation Combination Product: benralizumab Benralizumab. SC injection.
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.	Combination Product: ICS-LABA ICS-LABA inhalation Combination Product: Placebo for Benralizumab Placebo for Benralizumab (aka, “placebo”). SC injection.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Sandeep Bansal

Clinical Research Associates of Central PA