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RECRUITING

NCT06750289

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-03-28

Completion Date

2027-11-03

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Eosinophilic Asthma

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.

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.

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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Modesto, California, United States

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Newport Beach, 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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Hialeah, Florida, United States

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Lauderdale Lakes, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Ann Arbor, Michigan, United States

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Henderson, Nevada, United States

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Northfield, New Jersey, United States

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Union City, 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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Jinan, 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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München-Pasing, Germany

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Neu-Isenburg, Germany

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Wiesbaden, Germany

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Witten, 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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Moneymore, Ireland

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Bari, Italy

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Bergamo, Italy

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Brescia, Italy

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Cagliari, Italy

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Catanzaro, Italy

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Genoa, Italy

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Milan, Italy

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Modena, Italy

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Montebelluna, 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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Verona, 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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Barakaldo, Spain

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Barcelona, Spain

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Barcelona, Spain

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Burgos, Spain

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Cáceres, Spain

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Granada, Spain

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Jerez de la Frontera, Spain

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Lugo, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Marbella, Spain

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Marbella, Spain

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Málaga, Spain

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Mérida, Spain

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Palma de Mallorca, Spain

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Santander, Spain

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Aarau, Switzerland

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Basel, Switzerland

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Lausanne, Switzerland

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Sankt Gallen, Switzerland

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Sion, Switzerland

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Bradford, United Kingdom

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Bristol, United Kingdom

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Chorley, United Kingdom

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Leeds, United Kingdom

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Liverpool, United Kingdom

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Nottingham, United Kingdom

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Portsmouth, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (157)