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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 · AstraZeneca
In plain English

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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.
About this study
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).
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.
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2025-03-28
Estimated completion: 2027-11-03
Last updated: 2026-03-19
Interventions
Combination Product: ICS-LABACombination Product: benralizumabCombination Product: Placebo for Benralizumab
Primary outcomes
  • Annualized asthma exacerbation rate (Baseline through Week 48)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (157)
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Chandler, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Bakersfield, California, United States
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Inglewood, California, United States
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Pasadena, California, United States
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Denver, Colorado, United States
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Cape Coral, Florida, United States
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Henderson, Nevada, United States
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Northfield, New Jersey, United States
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New Hyde Park, New York, United States
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The Bronx, New York, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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DuBois, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Greenville, South Carolina, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Dimitrovgrad, Bulgaria
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Haskovo, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Stara Zagora, Bulgaria
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Edmonton, Alberta, Canada
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Kamloops, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changsha, China
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Chongqing, China
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Fuzhou, China
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Fuzhou, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hefei, China
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Huizhou, China
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Linyi, China
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Ningbo, China
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Qinhuangdao, China
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Shanghai, China
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Shanghai, China
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Wenzhou, China
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Wuhan, China
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Xuzhou, China
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Yinchuan, China
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Zhengzhou, China
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Bayonne, France
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Créteil, France
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La Tronche, France
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Lyon, France
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Montpellier, France
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Pessac, France
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Suresnes, France
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Toulouse, France
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Villeurbanne, France
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Berlin, Germany
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Berlin, Germany
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Bonn, Germany
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Cottbus, Germany
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Delitzsch, Germany
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Geesthacht, Germany
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Landsberg, Germany
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Lübeck, Germany
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Mönchengladbach, Germany
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München, Germany
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Neu-Isenburg, Germany
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Wiesbaden, Germany
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Zossen, Germany
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Hong Kong, Hong Kong
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Pok Fu Lam, Hong Kong
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Shatin, Hong Kong
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Ballinasloe, Ireland
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Cork, Ireland
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Dublin, Ireland
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Genoa, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
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Roma, Italy
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Roma, Italy
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Rozzano, Italy
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Lørenskog, Norway
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Alcorcón, Spain
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Alzira (Valencia), Spain
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Badalona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Burgos, Spain
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Liverpool, United Kingdom
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Nottingham, United Kingdom
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Portsmouth, United Kingdom
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 · TrialPath