Asthma
Conditions
Interventions
Drug: Tozorakimab/Placebo
Subcutaneous administration of tozorakimab 300 mg Q2W or 300 mg Q4W.
Other Name: MEDI3506
Sponsors
Ageishi Yuji
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated written informed consent prior to anystudy-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 an ACQ-6 score of 1.5 or more . 6. Pre-bronchodilator FEV1 between 40% and 90% of predicted normal. 7. Documented exacerbation history in the last 12 months and biomarkerrequirements of: (a) 2 severe exacerbations OR (b) 1 severe exacerbation and: (i) Eosinophils count is 150 cells/uL or more, or (ii) FeNo is 25 ppb or more 8. Participants need to demonstrate a compliance rate of 70% or more for Asthma Daily Diary. 9. Women of Child Bearing Potential (WOCBP) must have a negativepregnancy test. 10. Contraceptive use by males and females should be consistent withlocal regulations regarding the methods of contraception for thoseparticipating in clinical studies.
Exclusion criteria
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 orimmune complex disease. 6. Unstable cardiovascular disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint: Annualised rate of severe asthma exacerbations The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and at least 1 severe exacerbation within 12 months prior to screening. | — |
Countries
Argentina, Brazil, Chile, China, France, Greece, Hungary, India, Israel, Italy, Japan, Peru, Philippines, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Staes, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed