Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (Umbriel)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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:
- 2 severe exacerbations OR
- 1 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Asthma
Age
18 - 75
Phase
Phase 2
Participants needed
540
Est. Completion Date
Mar 16, 2028
Treatment type
Interventional
ClinicalTrials.gov identifier
NCT06932263
Study number
D9181C00002
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