RecruitingPhase 2NCT06932263

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

Sponsor

AstraZeneca

Enrollment

540 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called tozorakimab to see if it can help adults whose asthma is not well controlled, even with strong inhaler medications. Researchers want to find the right dose and check how safe the drug is. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with asthma for at least 12 months - You are already using a medium or high-dose steroid inhaler combined with a long-acting bronchodilator (a second type of inhaler) - Your asthma is still not well controlled despite these medications - You have had 2 or more severe asthma attacks in the past year, OR 1 severe attack plus elevated allergy-related blood markers - Your lung function tests show moderate impairment **You may NOT be eligible if...** - You recently used antibiotics for a respiratory infection (within the last 4 weeks) - You have a significant lung disease other than asthma - You are a current smoker, or a former heavy smoker (more than 10 pack-years) - You have serious heart or blood vessel problems - You have active tuberculosis, hepatitis, HIV, or cancer 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

DRUGTozorakimab

The drug will be administered subcutaneously.

DRUGPlacebo

Placebo will be administered subcutaneously.

Locations(209)

Research Site

Bakersfield, California, United States

Research Site

Huntington Beach, California, United States

Research Site

La Mesa, California, United States

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Newport Beach, California, United States

Research Site

San Jose, California, United States

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Wilmington, Delaware, United States

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Cutler Bay, Florida, United States

Research Site

Hialeah, Florida, United States

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Hialeah, 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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Orlando, Florida, United States

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Palmetto Bay, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Boise, Idaho, United States

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Indianapolis, Indiana, United States

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West Des Moines, Iowa, United States

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Louisville, Kentucky, United States

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White Marsh, Maryland, United States

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Farmington Hills, Michigan, United States

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Warren, Michigan, United States

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St Louis, Missouri, United States

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Bellevue, Nebraska, United States

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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Toms River, New Jersey, United States

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Maspeth, New York, United States

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Asheville, North Carolina, United States

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Huntersville, North Carolina, United States

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Kings Mountain, North Carolina, United States

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Toledo, Ohio, United States

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Edmond, Oklahoma, United States

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Grants Pass, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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DuBois, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Rock Hill, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Forney, Texas, United States

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Kingwood, Texas, United States

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Tyler, Texas, United States

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Victoria, Texas, United States

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Roy, Utah, United States

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Bellingham, Washington, United States

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Kingwood, West Virginia, United States

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Milwaukee, Wisconsin, United States

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CABA, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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La Plata, Argentina

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Mendoza, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Caxias do Sul, Brazil

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Criciúma, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Salvador, Brazil

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Santo André, Brazil

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São José do Rio Preto, 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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Curicó, Chile

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Quillota, Chile

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Santiago, Chile

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Santiago, Chile

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Santiago, Chile

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Temuco, Chile

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Viña del Mar, Chile

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Baotou, China

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Changchun, China

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Chengdu, China

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Chongqing, China

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Guangzhou, China

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Haikou, China

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Hefei, China

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Hohhot, China

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Huizhou, China

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Qingdao, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shenzhen, China

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Wenzhou, China

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Xuzhou, China

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Brest, France

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Créteil, France

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Lyon, France

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Marseille, France

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Pessac, France

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Strasbourg, France

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Suresnes, France

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Athens, Greece

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Athens, Greece

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Ioannina, Greece

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Pátrai, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Balassagyarmat, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Gödöllő, Hungary

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Pécs, Hungary

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Törökbálint, Hungary

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Belagavi, India

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Coimbatore, India

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Dehradun, India

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Delhi, India

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Faridabad, India

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Gurgaon, India

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Kochi, India

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Lucknow, India

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New Delhi, India

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Vadodara, India

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Haifa, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Catania, Italy

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Foggia, Italy

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Genoa, Italy

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Roma, Italy

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Fukuoka, Japan

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Ginowan-shi, Japan

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Hiroshima, Japan

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Ishinomaki, Japan

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Kawaguchi-shi, Japan

Research Site

Kiyose-shi, Japan

Research Site

Kobe, Japan

Research Site

Meguro-ku, Japan

Research Site

Miura, Japan

Research Site

Neyagawa, Japan

Research Site

Sapporo, Japan

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Sapporo, Japan

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Takamatsu, Japan

Research Site

Ube, Japan

Research Site

Yokohama, Japan

Research Site

Yokohama, Japan

Research Site

Yokohama, Japan

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Lima, Peru

Research Site

Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Iloilo City, Philippines

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Las Piñas, Philippines

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Lipa City, Philippines

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Manadaluyong City, Philippines

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Quezon City, Philippines

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Roxas City, Philippines

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Bellville, South Africa

Research Site

Benoni, South Africa

Research Site

Brackenfell, South Africa

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Cape Town, South Africa

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Durban, South Africa

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eMkhomazi, South Africa

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Somerset West, South Africa

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Cheongju-si, South Korea

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Daegu, 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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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Málaga, Spain

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Mérida, Spain

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Patraix, Spain

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Santander, Spain

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Chanthaburi, Thailand

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Chiang Rai, Thailand

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Chon Buri, Thailand

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Khon Kaen, Thailand

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Nakhon Sri Thammarat, Thailand

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Da Nang, Vietnam

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Haiphong, Vietnam

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

Research Site

Ho Chi Minh City, Vietnam

Research Site

Ho Chi Minh City, Vietnam

Research Site

Huế, Vietnam

View Full Details on ClinicalTrials.gov

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NCT06932263

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