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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported