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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT03347279

Run by

AstraZeneca

People needed

1061

Starts

2017-11-23

Expected to finish

2020-11-12

Last updated by the study team

2021-11-26

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Foley, Alabama, United States
• Research Site — Gilbert, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Bakersfield, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Northridge, California, United States
• Research Site — Palm Desert, California, United States
• Research Site — Rolling Hills Estates, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Westminster, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Celebration, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Panama City, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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