RecruitingPhase 3NCT06750289

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: 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.

Sponsor

AstraZeneca

Enrollment

400 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Eosinophilic Asthma

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.

Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for managing uncontrolled eosinophilic asthma (a type of asthma driven by high levels of a blood cell called eosinophil) in people already on medium-dose inhaled steroids and a long-acting bronchodilator. One approach adds benralizumab (a biologic injection that depletes eosinophils); the other steps up to higher-dose inhaled steroids. **You may be eligible if...** - You are between 12 and 75 years old - You have had doctor-diagnosed asthma for at least 12 months - You have been on medium-dose inhaled steroids plus a long-acting bronchodilator for at least 3 months - You have had at least 2 asthma flare-ups (exacerbations) in the past 12 months - Your breathing test shows reduced lung function (FEV1 at or below 90% predicted) - Your asthma control score (ACQ-6) indicates poor control - You weigh at least 35 kg **You may NOT be eligible if...** - You are currently on oral steroids for asthma - You have already received biologic therapy for asthma - You smoke heavily or have significant other lung diseases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTICS-LABA

ICS-LABA inhalation

COMBINATION_PRODUCTbenralizumab

Benralizumab. SC injection.

COMBINATION_PRODUCTPlacebo for Benralizumab

Placebo for Benralizumab (aka, "placebo"). SC injection.

Locations(157)

Research Site

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

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NCT06750289

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