RecruitingPhase 3NCT05692180

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Sponsor

AstraZeneca

Enrollment

200 participants

Start Date

Apr 5, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (DOMINICA) tests whether benralizumab — a biologic injection that targets a protein driving severe asthma — can reduce asthma attacks in children aged 6 to 17 with severe eosinophilic asthma (a type driven by high levels of a white blood cell called eosinophils). **You may be eligible if...** - Your child is between 6 and 17 years old - Your child has been diagnosed with severe eosinophilic asthma for at least 12 months - Your child has had at least one serious asthma attack in the past year requiring steroids or hospitalization - Your child is already on maximum standard asthma medications (high-dose inhaled steroids plus at least one additional controller) - Blood tests show elevated eosinophil levels - You (and your child, if able) can provide consent and assent **You may NOT be eligible if...** - Your child is under 6 or 18 or older - Your child's asthma does not have an eosinophilic pattern - Your child has had a serious allergic reaction to a biologic injection previously - Your child has other serious lung, heart, or immune conditions 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

DRUGBenralizumab

Benralizumab active solution will be administered SC to the patients.

DRUGPlacebo

Placebo solution will be administered SC to the patients.

Locations(116)

Research Site

Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Madera, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Owensboro, Kentucky, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Glenn Dale, Maryland, United States

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Boston, Massachusetts, United States

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Ridgeland, Mississippi, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Brick, New Jersey, United States

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Northfield, New Jersey, United States

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The Bronx, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Morgantown, West Virginia, United States

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aire, Argentina

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Florida, Argentina

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Lobos, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Rosario, Argentina

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San Juan Bautista, Argentina

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Santa Fe, Argentina

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Edmonton, Alberta, Canada

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Burlington, Ontario, Canada

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Hamilton, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Créteil, France

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Lyon, France

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Montpellier, France

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Nice, France

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Paris, France

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Rouen, France

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Toulouse, France

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Essen, Germany

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Wesel, Germany

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Belagavi, India

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Bikaner, India

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Hanamkonda, India

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Jaipur, India

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Jaipur, India

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Kolhāpur, India

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Ludhiana, India

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Nagpur, India

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Nellore, India

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Pune, India

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Raipur, India

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Sheikhpura, India

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Genova, Italy

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Milan, Italy

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Pavia, Italy

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Ponte San Pietro, Italy

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Roma, Italy

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Roma, Italy

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Verona, Italy

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Bialystok, Poland

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Krakow, Poland

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Lodz, Poland

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Rzeszów, Poland

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Skarżysko-Kamienna, Poland

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Tarnów, Poland

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Belgrade, Serbia

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Belgrade, Serbia

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Belgrade, Serbia

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Kragujevac, Serbia

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Novi Sad, Serbia

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Bellville, South Africa

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Benoni, South Africa

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Cape Town, South Africa

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Centurion, South Africa

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Durban, South Africa

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Durban, South Africa

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Durban, South Africa

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Germiston, South Africa

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Krugersdorp, South Africa

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Lenasia, South Africa

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Pietermaritzburg, South Africa

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Cheongju-si, South Korea

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Junggu, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Badalona, Spain

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Barcelona, Spain

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Benalmádena, Spain

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Cartagena, Spain

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Esplugues de Llobregat, Spain

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Madrid, Spain

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Mérida, Spain

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Valencia, Spain

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Glasgow, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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NCT05692180

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