NCT06932263 · AstraZeneca
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
(Umbriel)
What this study is about
This is a dose-range finding, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, phase IIb study designed to assess effectiveness and safety of tozorakimab administered injected under the skin in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
View original scientific description
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 outcome measures
Annualised rate of severe asthma exacerbations
Time frame: Over 26 to 52 weeks
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Exclusi
Where
- Bakersfield, California
- Huntington Beach, California
- La Mesa, California
- Newport Beach, California
- San Jose, California
- Wilmington, Delaware
- Cutler Bay, Florida
- Hialeah, Florida
- Leesburg, Florida
- Miami, Florida
- Orlando, Florida
- Palmetto Bay, Florida
And 41 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations