Last updated on May 2020

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: Between 12 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age. 12-80
  • Documented physician-diagnosed asthma for at least 12 months
  • Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
  • Documented treatment with a total daily dose of either medium or high dose ICS ( 500 g fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
  • 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.
  • Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)
  • 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.
  • Documented history of at least 2 asthma exacerbation events within 12 months.
  • ACQ-6 score 1.5 at screening and on day of randomization

Exclusion Criteria:

  • Pulmonary disease other than asthma.
  • History of cancer.
  • History of a clinically significant infection.
  • Current smokers or subjects with smoking history 10 pack-years and subjects using vaping products, including electronic cigarettes.
  • History of chronic alcohol or drug abuse within 12 months.
  • Hepatitis B, C or HIV.
  • Pregnant or breastfeeding.
  • History of anaphylaxis following any biologic therapy.
  • Subject randomized in the current study or previous tezepelumab studies.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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