Recruiting
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults 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.
ClinicalTrials.gov IDNCT06932263
PhasePHASE2
Enrollment540
SponsorAstraZeneca
Age18 Years
SexALL
Conditions studied
Asthma
About this 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.
Interventions
- Drug: Tozorakimab — The drug will be administered subcutaneously.
- Drug: Placebo — Placebo will be administered subcutaneously.
Primary outcomes
- Annualised rate of severe asthma exacerbations (Over 26 to 52 weeks)
Eligibility information
Inclusion Criteria:
1. Provision of signed and dated written informed consent prior to any study-specific procedures.
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:
1. ≥ 2 severe exacerbations OR
2. 1 severe exacerbation and:
(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. 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:
1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with \>10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
6. Unstable cardiovascular disorders.
Study locations
- Research Site, Bakersfield, California 93301 United States
- Research Site, Huntington Beach, California 92647 United States
- Research Site, La Mesa, California 91942 United States
- Research Site, Loma Linda, California 92354 United States
- Research Site, Long Beach, California 90815 United States
- Research Site, Newport Beach, California 92663 United States
- Research Site, San Jose, California 95117 United States
- Research Site, Wilmington, Delaware 19805 United States
- Research Site, Cutler Bay, Florida 33189 United States
- Research Site, Hialeah, Florida 33015 United States
Showing 10 of 222 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.