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

Launched by ASTRAZENECA · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called tozorakimab to see if it can help adults with asthma who are not able to control their symptoms, even while using other asthma treatments. The trial will look at different doses of tozorakimab to find the most effective and safest amount to use. Participants will receive either the medication or a placebo (a substance with no active medication) without knowing which one they are getting, ensuring a fair comparison.

To join this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of asthma for at least a year. They should also be currently using medium to high doses of inhaled corticosteroids and still have uncontrolled asthma symptoms. Eligible participants must have experienced serious asthma flare-ups recently and meet other specific health criteria. If someone chooses to participate, they can expect regular check-ups and monitoring throughout the trial to assess their condition and how well the medication is working.

Gender

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Eligibility 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:
• • 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.