Overview
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
Description
This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel
group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of
tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at
least one additional asthma controller medication with or without OCS. Approximately 396
subjects will be randomized regionally (China/non-China). Subjects will receive tezepelumab,
or placebo, administered via subcutaneous injection at the study site, over a 52-week
treatment period. The study also includes a post-treatment follow-up period of 12 weeks.
Eligibility
Inclusion Criteria:
Age. 18-80
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 6 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
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, and at
least one of the exacerbations should occur during the treatment of medium-to-high
dose ICS.
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-yrs.
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.