For Healthcare Professionals

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

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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
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Who can take part

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

INCLUSION 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

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


Contition

Asthma

Age (in years)

18 - 80

Phase

Phase 3

Participants needed

405

Est. Completion Date

Aug 19, 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT03927157

Study number

D5180C00021

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