A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
AstraZeneca
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTozorakimab
The drug will be administered subcutaneously.
- DrugPlacebo
Placebo will be administered subcutaneously.
Locations (209)
- Research SiteBakersfield, California
- Research SiteHuntington Beach, California
- Research SiteLa Mesa, California
- Research SiteNewport Beach, California
- Research SiteSan Jose, California
- Research SiteWilmington, Delaware