RecruitingPhase 2NCT06932263
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults 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
Sponsor
AstraZeneca
Enrollment
540 participants
Start Date
Mar 26, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria13
- 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:
- severe exacerbations OR
- 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.
Exclusion Criteria6
- 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.
- Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
- Unstable cardiovascular disorders.
Interventions
DRUGTozorakimab
The drug will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
Locations(208)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06932263
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