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

Prior treatment

• Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
• Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1.

Other illness

• Clinically significant pulmonary disease other than asthma.
• Clinically significant aortic stenosis or pulmonary arterial hypertension.
• Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
• Unstable cardiovascular disorders.

• Provision of signed and dated written informed consent prior to any study-specific procedures.
• Women of Child Bearing Potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to randomisation.
• Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Optional: Provision of signed and dated written Optional Genetic Research Information informed consent before the sample collection or optional genetic research that supports the Genomic Initiative.
• Adults aged 18-75, inclusive when signing the informed consent at Visit 1.
• Documented physician-diagnosis of asthma for at least 12 months prior to V1.
• Treated with medium or high dose ICS (as per GINA 2024 report) in combination with LABA.
• Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 at screening and randomisation.
• Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal at both screening and randomisation.
• Documented exacerbation history in the last 12 months before screening and biomarker requirements of: (a) 2 severe exacerbations OR (b) 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/μl at screening or (ii) FeNo ≥ 25 ppb at screening and randomisation (Visits 1 and 2)
• Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.