Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
NCT ID: NCT05329194
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
287 participants
INTERVENTIONAL
2022-04-29
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tezepelumab
Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.
Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab.
Interventions
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Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Njira Lugogo., MD.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Health. Michigan, USA
Locations
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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
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
Research Site
Chicago, Illinois, United States
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Lexington, Kentucky, United States
Research Site
New Orleans, Louisiana, United States
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Upper Marlboro, Maryland, United States
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Ann Arbor, Michigan, United States
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Ypsilanti, Michigan, United States
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Saint Paul, Minnesota, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Hollis, New York, United States
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Horseheads, New York, United States
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Rochester, New York, United States
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Valhalla, New York, United States
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Chapel Hill, North Carolina, United States
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Wilmington, North Carolina, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Greenville, South Carolina, United States
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Hendersonville, Tennessee, United States
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Fort Worth, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
Research Site
Vancouver, Washington, United States
Countries
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References
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Lugogo NL, Akuthota P, Sumino K, Mathur SK, Burnette AF, Lindsley AW, Llanos JP, Marchese C, Ambrose CS, Emmanuel B. Effectiveness and Safety of Tezepelumab in a Diverse Population of US Patients with Severe Asthma: Initial Results of the PASSAGE Study. Adv Ther. 2025 Jul;42(7):3334-3353. doi: 10.1007/s12325-025-03231-6. Epub 2025 May 19.
Other Identifiers
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D5180C00032
Identifier Type: -
Identifier Source: org_study_id
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