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

Inclusion 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:
• (a) 2 severe exacerbations
• OR
• (b) 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.