Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
PASSAGE
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)
1 other identifier
interventional
287
1 country
37
Brief Summary
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Apr 2022
Longer than P75 for phase_4 asthma
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
April 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedOctober 14, 2025
October 1, 2025
3.4 years
March 17, 2022
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Annualized asthma exacerbation rate (AAER)
Asthma exacerbation will be defined by worsening of asthma symptoms that leads to temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days, or an emergency department (ED) or urgent care visit due to asthma that required systemic corticosteroid (SCS), and/or inpatient hospitalization (≥24 hours) due to asthma. The AAER is based on exacerbations reported by the investigator over 52 weeks. The exacerbation rate will be compared between the 12 month period before (baseline period) and the 12 month period after initiation of tezepelumab (up to study Week 52 - study period).
Baseline period up to study Week 52
Proportion of participants with asthma exacerbations
The proportion of participants with asthma exacerbations in the 12 month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52 - study period) will be assessed.
Baseline period up to study Week 52
Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations
The proportion of participants who completed the 52 -week study period following tezepelumab initiation with any reduction, at least 50% reduction, and 100% reduction in total number of asthma exacerbations will be assessed.
Baseline period up to study Week 52
Cumulative asthma exacerbation days
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Baseline period up to study Week 52
Secondary Outcomes (32)
Time to first asthma exacerbation
Week 0 to Week 52
Rate of asthma exacerbations associated with hospitalizations
Baseline period up to study Week 52
Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits
Baseline period up to study Week 52
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over
Baseline period up to study Week 52
Proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits
Baseline period up to study Week 52
- +27 more secondary outcomes
Other Outcomes (1)
Number of participants with serious adverse events, adverse events that lead to tezepelumab treatment discontinuation, and adverse events of special interest
Week 0 to Week 52
Study Arms (1)
Tezepelumab
EXPERIMENTALParticipants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.
Interventions
Participants will be receiving subcutaneous injection of tezepelumab.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (37)
Research Site
Mobile, Alabama, 36608, United States
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Long Beach, California, 90815, United States
Research Site
Los Angeles, California, 90017, United States
Research Site
Rancho Mirage, California, 92270, United States
Research Site
Westminster, California, 92683, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
Washington D.C., District of Columbia, 20037, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Lexington, Kentucky, 40509, United States
Research Site
New Orleans, Louisiana, 70112, United States
Research Site
Upper Marlboro, Maryland, 20772, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Ypsilanti, Michigan, 48197, United States
Research Site
Saint Paul, Minnesota, 55109, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Lincoln, Nebraska, 68505, United States
Research Site
Omaha, Nebraska, 68114, United States
Research Site
Hollis, New York, 11423, United States
Research Site
Horseheads, New York, 14845, United States
Research Site
Rochester, New York, 14642, United States
Research Site
Valhalla, New York, 10595, United States
Research Site
Chapel Hill, North Carolina, 27514, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Toledo, Ohio, 43617, United States
Research Site
Oklahoma City, Oklahoma, 73120, United States
Research Site
Altoona, Pennsylvania, 16602, United States
Research Site
Philadelphia, Pennsylvania, 19140, United States
Research Site
Warwick, Rhode Island, 02886, United States
Research Site
Greenville, South Carolina, 29607, United States
Research Site
Hendersonville, Tennessee, 37075, United States
Research Site
Fort Worth, Texas, 76104, United States
Research Site
McKinney, Texas, 75069, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Charlottesville, Virginia, 22903, United States
Research Site
Vancouver, Washington, 98664, United States
Related Publications (1)
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.
PMID: 40388086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Njira Lugogo., MD.
University of Michigan Health. Michigan, USA
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2022
First Posted
April 14, 2022
Study Start
April 29, 2022
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.