Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States

Completed · Phase 4

Conditions studied: Asthma

In brief

To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.

Key facts

Study ID: NCT05329194
Run by: AstraZeneca
People needed: 286
Starts: 2022-04-29
Expected to finish: 2025-10-01
Last updated by the study team: 2026-07-16

Who can join

Age: 12 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment.
Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
Provision of signed and dated written informed consent form.

You may not qualify if…

Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment.
Participation in an interventional clinical trial for asthma within 12 months prior to enrollment.
Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

Where it is running

Research Site — Mobile, Alabama, United States
Research Site — Gilbert, Arizona, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Rancho Mirage, California, United States
Research Site — Westminster, California, United States
Research Site — Colorado Springs, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Chicago, Illinois, United States
Research Site — Lexington, Kentucky, United States
Research Site — New Orleans, Louisiana, United States
Research Site — Upper Marlboro, Maryland, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Ypsilanti, Michigan, United States
Research Site — Saint Paul, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — Lincoln, Nebraska, United States
Research Site — Omaha, Nebraska, United States
Research Site — Hollis, New York, United States
Research Site — Horseheads, New York, United States
Research Site — Rochester, New York, United States
Research Site — Valhalla, New York, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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