Last updated 29 days ago
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
540 patients around the world
Available in Chile, Peru, Brazil, Argentina, United States
AstraZeneca
1Research sites
540Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.2 severe exacerbations OR.1 severe exacerbation and.Eosinophils ≥ 150 cells/µl.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.
- 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.
Sites
Centro de Investigaciones Médicas Respiratorias (CIMER) - Chile
Recruiting
StudyUmbriel
SponsorAstraZeneca
Study typeInterventional
Conditions
Asthma
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06932263
