About the study

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participant must be 18 to 80 years of age.
2. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
3. Participants must have received a physician-prescribed medium
4. or high-dose ICS for at least 12 months prior to Visit 1.
5. Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
6. Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1.
7. Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1.
8. Morning pre
9. bronchodilator (BD) FEV1 must be < 80% predicted normal at Visit 1 or Visit 2. a) Post-BD responsiveness test result: FEV1 ≥12% and ≥200 mL documented either in the previous 60 months prior to or at Visit 1 or at Visit 2 or at Visit 3; OR b)Airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 60 months prior to Visit 1.
10. Blood eosinophils at Visit 1 ≥150 cells/μL or documented EOS ≥300 cells/μL within 12 months prior to Visit 1.
11. Participants must have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1.
12. Participants must have received the optimised OCS dose for at least 2 weeks prior to randomisation. Other inclusion criteria per protocol apply. Main

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.