Recruiting NCT06750289

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

Phase III Interventional Eosinophilic Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ICS-LABA, benralizumab, Placebo for Benralizumab.
Who it may be relevant to: Registry conditions: Eosinophilic Asthma. Basic parameters: 12 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Bulgaria, Canada, China, France +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Detailed description

This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Interventions

Combination product ICS-LABA
ICS-LABA inhalation
Combination product benralizumab
Benralizumab. SC injection.
Combination product Placebo for Benralizumab
Placebo for Benralizumab (aka, "placebo"). SC injection.

Primary outcome measures

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

Secondary outcome measures (7)

Change in Saint George's Respiratory Questionnaire (SGRQ) total score [Time frame: Baseline through Week 48]
Change in pre-bronchodilator FEV1 [Time frame: Baseline through Week 48]
Change in Asthma control questionnaire (ACQ) scale score. [Time frame: Baseline through Week 48.]
Time to first asthma exacerbation [Time frame: Baseline through Week 48.]
Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization [Time frame: Baseline through Week 48.]
Number and proportion of participants that meet each component of a 4-component clinical remission composite [Time frame: Week 24 and Week 48.]
Safety Adverse Event (AEs), Serious Adverse Event (SAEs), Adverse event leading to treatment discontinuation (DAEs.) [Time frame: Baseline through Week 48.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 34 centers

Research Site — Chandler
Research Site — Sun City
Research Site — Tucson
Research Site — Bakersfield
Research Site — Inglewood
Research Site — Modesto
Research Site — Newport Beach
Research Site — Pasadena
… and 26 more centers

China · 25 centers

Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Changsha
Research Site — Chongqing
Research Site — Fuzhou
Research Site — Fuzhou
Research Site — Fuzhou
… and 17 more centers

Spain · 20 centers