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Dose Range Finding Study to Access Efficacy and Safety of Tozorakimab in Adults with Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
EU CTIS ID: 2024-519116-14-00
What this study is testing
To evaluate the effect of two dose levels of tozorakimab compared with placebo on annualised rate of severe asthma exacerbations.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Provision of signed and dated written informed consent prior to any study-specific procedures.
- 10. Women of Child Bearing Potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to randomisation.
- 11. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 2. Optional: Provision of signed and dated written Optional Genetic Research Information informed consent before the sample collection or optional genetic research that supports the Genomic Initiative.
- 3. Adults aged 18-75, inclusive when signing the informed consent at Visit 1.
- 4. Documented physician-diagnosis of asthma for at least 12 months prior to V1.
You likely can't join if
- 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, or former smokers who stopped smoking <6 months before Visit 1.
- 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.
See the full eligibility criteria
- 1. Provision of signed and dated written informed consent prior to any study-specific procedures.
- 10. Women of Child Bearing Potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to randomisation.
- 11. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 2. Optional: Provision of signed and dated written Optional Genetic Research Information informed consent before the sample collection or optional genetic research that supports the Genomic Initiative.
- 3. Adults aged 18-75, inclusive when signing the informed consent at Visit 1.
- 4. Documented physician-diagnosis of asthma for at least 12 months prior to V1.
- 5. Treated with medium or high dose ICS (as per GINA 2024 report) in combination with LABA.
- 6. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 at screening and randomisation.
- 7. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal at both screening and randomisation.
- 8. Documented exacerbation history in the last 12 months before screening and biomarker requirements of: (a) 2 severe exacerbations OR (b) 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/μl at screening or (ii) FeNo ≥ 25 ppb at screening and randomisation (Visits 1 and 2)
- 9. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
- 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, or former smokers who stopped smoking <6 months before Visit 1.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- South Africa
- Taiwan
- Philippines
- Argentina
- Chile
- Vietnam
- Korea, Republic of
- Brazil
- Israel
- Thailand
- India
- United States
- Peru
- Japan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; South Africa; Taiwan; Philippines; Argentina; Chile and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.