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
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
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.
Inclusion Criteria:
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:
(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.
Exclusion Criteria:
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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