For Healthcare Professionals

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma


About the study

A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma

Who can take part

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


Inclusion Criteria:

  1. Age. 18-80
  2. Documented physician-diagnosed asthma for at least 12 months
  3. Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
  4. Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
  5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
  6. Morning pre-BD FEV1 <80% predicted normal
  7. Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
  8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
  9. ACQ-6 score ≥1.5 at screening and on day of randomization


Exclusion Criteria:

  1. Pulmonary disease other than asthma.
  2. History of cancer.
  3. History of a clinically significant infection.
  4. Current smokers or participants with smoking history ≥10 pack-yrs.
  5. History of chronic alcohol or drug abuse within 12 months.
  6. Hepatitis B, C or HIV.
  7. Pregnant or breastfeeding.
  8. History of anaphylaxis following any biologic therapy.
  9. participant randomized in the current study or previous tezepelumab studies.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details



Age (in years)

18 - 80


Phase 3

Participants needed


Est. Completion Date

Aug 19, 2024

Treatment type



AstraZeneca identifier


Study number


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