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

Korábbi kezelés

• Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.

Más betegség

• 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.

Egyéb

• Current smokers, former smokers with >10 pack-years history.

• 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:
  • ≥ 2 severe exacerbations OR
  • 1 severe exacerbation and:
  • (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
• 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.