RecruitingAsthma

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

27 states

Healthy volunteers

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About this study

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.

Sponsor: AstraZeneca

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.