Last updated on July 2019

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: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.