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

RecruitingPhase 2Ages 18 Years - 75 YearsAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Tozorakimab
  • Placebo
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Where

222 sites
Research Site
Bakersfield, United States
Research Site
Huntington Beach, United States
Research Site
La Mesa, United States
Research Site
Loma Linda, United States
Research Site
Long Beach, United States
Research Site
Newport Beach, United States
Research Site
San Jose, United States
Research Site
Wilmington, United States

…and 214 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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