RecruitingPhase 3NCT06023589

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)

Sponsor

AstraZeneca

Enrollment

231 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Eligibility

Min Age: 5 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tezepelumab, an injectable medication that blocks a protein involved in allergic inflammation, can help children aged 5 to 11 with severe asthma that isn't well controlled with current medications. Tezepelumab is already approved for older patients and adults — this study expands it to younger children. **You may be eligible if...** - Your child is between 5 and 11 years old - Your child has had a confirmed diagnosis of severe asthma for at least 6 months - Your child has had at least 2 severe asthma attacks (or 1 requiring hospitalization) in the past year - Your child is already on medium or high-dose inhaled steroids plus another asthma controller medication - Your child's asthma remains uncontrolled despite treatment **You may NOT be eligible if...** - Your child has conditions like cystic fibrosis, vocal cord dysfunction, or primary ciliary dyskinesia - Your child had a severe asthma flare or changed inhaler doses in the past month - Your child has ever had a life-threatening asthma attack that required a breathing tube 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

BIOLOGICALTezepelumab

Participants will be receiving subcutaneous injection of tezepelumab

OTHERPlacebo

Participants will be receiving subcutaneous injection of matching placebo

Locations(143)

Research Site

Montgomery, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Orange, California, United States

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San Diego, California, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Northfield, New Jersey, United States

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Hawthorne, New York, United States

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Schenectady, New York, United States

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Staten Island, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Columbia, South Carolina, United States

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Coppell, Texas, United States

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Dallas, Texas, United States

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Frisco, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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CABA, Argentina

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Florida, Argentina

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Lanus, Argentina

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Lobos, Argentina

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Mendoza, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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Blumenau, Brazil

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Curitiba, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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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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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Changchun, China

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Lanzhou, China

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Nanjing, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenzhen, China

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Wuxi, China

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Bogotá, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Brest, France

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Bron, France

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Créteil, France

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Marseille, France

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Paris, France

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Paris, France

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Paris, France

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Rouen, France

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Vandœuvre-lès-Nancy, France

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Debrecen, Hungary

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Szeged, Hungary

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Szigetvár, Hungary

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Genova, Italy

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Pavia, Italy

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Roma, Italy

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Fukuoka, Japan

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Fukuoka, Japan

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Fukuyama, Japan

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Funabashi-shi, Japan

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Nara, Japan

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Odawara, Japan

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Ōtsu, Japan

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Saga, Japan

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Shimotsuga-gun, Japan

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Yokohama, Japan

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Chihuahua City, Mexico

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Guadalajara, Mexico

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Mexico City, Mexico

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Veracruz, Mexico

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Amsterdam, Netherlands

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Rotterdam, Netherlands

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Iloilo City, Philippines

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Las Piñas, Philippines

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Quezon, Philippines

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Santa Rosa, Philippines

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Lodz, Poland

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Tarnów, Poland

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Bucharest, Romania

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Bucharest, Romania

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Bellville, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Durban, South Africa

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Middelburg, South Africa

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Thabazimbi, South Africa

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Vereeniging, South Africa

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Welkom, South Africa

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Seongnam-si, South Korea

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Seongnam-si, 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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Esplugues de Llobregat (Barc), Spain

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Madrid, Spain

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Sabadell, Spain

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Valencia, Spain

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Valencia, Spain

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Villarreal, Spain

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Bangkok, Thailand

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Bangkoknoi, Thailand

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Chiang Mai, Thailand

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Muang, Thailand

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Bursa, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Yenimahalle, Turkey (Türkiye)

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Chernivtsi, Ukraine

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Ivano-Frankivsk, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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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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Glasgow, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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Nottingham, United Kingdom

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Stoke-on-Trent, United Kingdom

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NCT06023589

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