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Search / Trial NCT06890351

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

Launched by ASTRAZENECA · Mar 20, 2025

Trial Information

Current as of April 30, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called tozorakimab to see if it can help adults with asthma who are not able to control their symptoms, even while using other asthma treatments. The trial will look at different doses of tozorakimab to find the most effective and safest amount to use. Participants will receive either the medication or a placebo (a substance with no active medication) without knowing which one they are getting, ensuring a fair comparison.

To join this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of asthma for at least a year. They should also be currently using medium to high doses of inhaled corticosteroids and still have uncontrolled asthma symptoms. Eligible participants must have experienced serious asthma flare-ups recently and meet other specific health criteria. If someone chooses to participate, they can expect regular check-ups and monitoring throughout the trial to assess their condition and how well the medication is working.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Provision of signed and dated written informed consent prior to any study-specific procedures.
  • 2. Adults aged 18-75, inclusive when signing the informed consent.
  • 3. Documented physician-diagnosis of asthma for at least 12 months.
  • 4. Treated with medium or high dose ICS in combination with LABA.
  • 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
  • 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
  • 7. Documented exacerbation history in the last 12 months and biomarker requirements of:
  • 1. 2 severe exacerbations OR
  • 2. 1 severe exacerbation and:
  • (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
  • 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
  • 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
  • 10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Exclusion Criteria:
  • 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
  • 2. Clinically significant pulmonary disease other than asthma .
  • 3. Current smokers, former smokers with \>10 pack-years history.
  • 4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
  • 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
  • 6. Unstable cardiovascular disorders.

About Astrazeneca

AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Tampa, Florida, United States

Saint Louis, Missouri, United States

Medford, Oregon, United States

Omaha, Nebraska, United States

Huntington Beach, California, United States

Jerusalem, , Israel

Madrid, , Spain

Barcelona, , Spain

Málaga, , Spain

Debrecen, , Hungary

Grand Island, Nebraska, United States

Asheville, North Carolina, United States

Philadelphia, Pennsylvania, United States

Tyler, Texas, United States

Bellingham, Washington, United States

Mendoza, , Argentina

Toledo, Ohio, United States

San Jose, California, United States

Athens, , Greece

Ioannina, , Greece

Foggia, , Italy

Roma, , Italy

Quezon City, , Philippines

Pécs, , Hungary

Taichung, , Taiwan

Törökbálint, , Hungary

Winter Park, Florida, United States

Miami, Florida, United States

Hialeah, Florida, United States

Pessac, , France

Huntersville, North Carolina, United States

Austin, Texas, United States

Budapest, , Hungary

Marseille, , France

Rock Hill, South Carolina, United States

West Des Moines, Iowa, United States

Grants Pass, Oregon, United States

Newport Beach, California, United States

Boise, Idaho, United States

Iloilo City, , Philippines

Lipa City, , Philippines

Taipei, , Taiwan

Bangkok, , Thailand

La Mesa, California, United States

San Miguel De Tucuman, , Argentina

Cape Town, , South Africa

Somerset West, , South Africa

Umkomaas, , South Africa

Kaohsiung, , Taiwan

Creteil, , France

Kingwood, Texas, United States

Leesburg, Florida, United States

Bakersfield, California, United States

Toms River, New Jersey, United States

Thessaloniki, , Greece

Genoa, , Italy

Maspeth, New York, United States

Victoria, Texas, United States

Rosario, , Argentina

Meguro Ku, , Japan

Kfar Saba, , Israel

Santander, , Spain

Catania, , Italy

Bellevue, Nebraska, United States

Portland, Oregon, United States

Palmetto Bay, Florida, United States

Louisville, Kentucky, United States

Farmington Hills, Michigan, United States

Smithfield, Pennsylvania, United States

Knoxville, Tennessee, United States

Cutler Bay, Florida, United States

Balassagyarmat, , Hungary

Gödöllő, , Hungary

Kiyose Shi, , Japan

Lyon Cedex 04, , France

Patras, , Greece

Taipei City, , Taiwan

Orlando, Florida, United States

Fukuoka Shi, , Japan

Takamatsu Shi, , Japan

Yokohama Shi, , Japan

Santo Andre, , Brazil

Sorocaba, , Brazil

Quillota, , Chile

White Marsh, Maryland, United States

Ciudad De Buenos Aires, , Argentina

Curico, , Chile

Khon Kaen, , Thailand

New Taipei, , Taiwan

Haifa, , Israel

Chonburi, , Thailand

Warren, Michigan, United States

Kobe Shi, , Japan

Lima, , Peru

Edmond, Oklahoma, United States

Buenos Aires, , Argentina

Ginowan Shi, , Japan

Chiang Rai, , Thailand

Benoni, , South Africa

Dubois, Pennsylvania, United States

Caxias Do Sul, , Brazil

Ube, , Japan

Suresnes, , France

Viña Del Mar, , Chile

Sao Jose Do Rio Preto, , Brazil

Las Pinas, , Philippines

Durban, , South Africa

Porto Alegre, , Brazil

Kagoshima City, , Japan

Roxas City, , Philippines

Mueang Chanthaburi, , Thailand

Tygervalley, , South Africa

Santiago, , Chile

Indianapolis, Indiana, United States

Manadaluyong City, , Philippines

Salvador, , Brazil

Forney, Texas, United States

Merida, , Spain

Brest Cedex, , France

Yokohama, , Japan

La Plata, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Victoria, , Chile

Taichung City, , Taiwan

Brackenfell, , South Africa

Wilmington, Delaware, United States

Kings Mountain, North Carolina, United States

Criciuma, , Brazil

Sao Paulo, , Brazil

Kawaguchi Shi, , Japan

Miura City, , Japan

Patraix, , Spain

Nakhon Sri Thammarat, , Thailand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported