Status:
RECRUITING
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 uncontrolle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 16 2028
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06932263
Start Date
March 26 2025
End Date
March 16 2028
Last Update
November 25 2025
Active Locations (208)
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1
Research Site
Bakersfield, California, United States, 93301
2
Research Site
Huntington Beach, California, United States, 92647
3
Research Site
La Mesa, California, United States, 91942
4
Research Site
Newport Beach, California, United States, 92663