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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Provision of signed and dated written informed consent prior to any study-specific procedures.
• Adults aged 18-75, inclusive when signing the informed consent.
• Documented physician-diagnosis of asthma for at least 12 months.
• Treated with medium or high dose ICS in combination with LABA.
• Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
• Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
• Documented exacerbation history in the last 12 months and biomarker requirements of: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
  • 2 severe exacerbations OR
  • 1 severe exacerbation and:
• Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
• Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
• Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

🚫 You may not be able to join if…

• Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
• Clinically significant pulmonary disease other than asthma .
• Current smokers, former smokers with >10 pack-years history.
• Clinically significant aortic stenosis or pulmonary arterial hypertension.
• Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
• Unstable cardiovascular disorders.

Where this trial is running

• Research Site, Bakersfield, California, United States
• Research Site, Huntington Beach, California, United States
• Research Site, La Mesa, California, United States
• Research Site, Newport Beach, California, United States
• Research Site, San Jose, California, United States
• Research Site, Wilmington, Delaware, United States
• Research Site, Cutler Bay, Florida, United States
• Research Site, Hialeah, Florida, United States
• Research Site, Hialeah, Florida, United States
• Research Site, Leesburg, Florida, United States
• Research Site, Miami, Florida, United States
• Research Site, Miami, Florida, United States

+ 201 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06932263.