Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Asthma

In brief

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous \[SC\] every 4 weeks \[Q4W\]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.

Key facts

Study ID: NCT05062759
Run by: AstraZeneca
People needed: 70
Starts: 2021-08-23
Expected to finish: 2022-07-18
Last updated by the study team: 2023-06-22

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
Morning pre-bronchodilator FEV1 (Forced expiratory volume) of > 50% predicted normal value at Visit 1 or Visit 2.
Body weight ≥ 40 kg.
For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
Must have 'not well-controlled' asthma.

You may not qualify if…

Clinically important pulmonary disease other than asthma.
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
Life-threatening asthma
History of cancer.
Allergy to eggs, if egg based influenza vaccine will be administered.
History of anaphylaxis to any biologic therapy.
Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
History of alcohol or drug abuse within 12 months prior to the date of informed consent.
Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.

Where it is running

Research Site — Bakersfield, California, United States
Research Site — Huntington Beach, California, United States
Research Site — Miami, Florida, United States
Research Site — Columbia, Missouri, United States
Research Site — Northfield, New Jersey, United States
Research Site — Dayton, Ohio, United States
Research Site — Toledo, Ohio, United States
Research Site — Edmond, Oklahoma, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — Dallas, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Tyler, Texas, United States
Research Site — Waco, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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