Study identifier:D5180C00032
ClinicalTrials.gov identifier:NCT05329194
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studied Populations in the United States (PASSAGE)
asthma
Phase 4
No
Tezepelumab
All
287
Interventional
12 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
PAREXEL
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults and adolescent participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ICS), with additional controller(s) for at least 12 months with documented history of at least 2 asthma exacerbations during the year prior to enrolment. The total duration of the study for each participant will be approximately 56 weeks. Approximately 400 participants will be enrolled. Participants will receive tezepelumab via subcutaneous injection at the study site, over a 48-week treatment period. The study also includes a post-dosing follow-up period from Weeks 48 to 52.
Location
Location
Ypsilanti, MI, United States, 48197
Location
Valhalla, NY, United States, 10595
Location
Altoona, PA, United States, 16602
Location
Mobile, AL, United States, 36608
Location
Fort Worth, TX, United States, 76107
Location
Ann Arbor, MI, United States, 48109
Location
Hollis, New York, United States, 11423
Location
Saint Paul, MN, United States, 55109
Arms | Assigned Interventions |
---|---|
Experimental: Tezepelumab Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48. | - |
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