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.
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.
Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
Clinically significant pulmonary disease other than asthma .
Current smokers, former smokers with >10 pack-years history.
Clinically significant aortic stenosis or pulmonary arterial hypertension.
Parallel
Tozorakimab
DrugThe drug will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
Annualised rate of severe asthma exacerbations
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.
Annualised rate of severe asthma exacerbations
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and baseline eosinophils \< 300 cells/µL and history of ≥2 severe exacerbations within 12 months prior to screening.
Time to first severe asthma exacerbation
To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations.
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Difference in mean change from baseline between tozorakimab and placebo.
Change from baseline in post-bronchodilator FEV1
Difference in mean change from baseline between tozorakimab and placebo.
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