Status:
COMPLETED
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
12-80 years
Phase:
PHASE3
Brief Summary
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
Detailed Description
This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolle...
Eligibility Criteria
Inclusion
- 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 µg 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
- 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.
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
1061 Patients enrolled
Trial Details
Trial ID
NCT03347279
Start Date
November 23 2017
End Date
November 12 2020
Last Update
November 26 2021
Active Locations (289)
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1
Research Site
Dothan, Alabama, United States, 36303
2
Research Site
Foley, Alabama, United States, 36535
3
Research Site
Gilbert, Arizona, United States, 85234
4
Research Site
Tucson, Arizona, United States, 85724