Clinical trial NCT05329194: Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Asthma
Keywords: Inhaled corticosteroids (ICS)
Post-Authorization
Baseline Blood eosinophil count (BEC)
long-acting- β2 Agonist (LABA)
Real-world participant population
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2022-04-14
Enrollment: 287
Sex: ALL
Minimum age (years): 12
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Annualized asthma exacerbation rate (AAER)
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants with asthma exacerbations
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations
timeFrame: Baseline period up to study Week 52
measure: Cumulative asthma exacerbation days
timeFrame: Baseline period up to study Week 52
Secondary outcomes:
measure: Time to first asthma exacerbation
timeFrame: Week 0 to Week 52
measure: Rate of asthma exacerbations associated with hospitalizations
timeFrame: Baseline period up to study Week 52
measure: Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits
timeFrame: Baseline period up to study Week 52
measure: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits
timeFrame: Baseline period up to study Week 52
measure: Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits
timeFrame: Baseline period up to study Week 52
measure: Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Change from baseline in pre-bronchodilator FEV1
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Proportion of pre-BD FEV1 responders
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Asthma Control Questionnaire (ACQ-6)
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Asthma Impairment and Risk Questionnaire (AIRQ)
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Change from baseline in ACQ-6 score
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Change from baseline in AIRQ score
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Change from baseline in SGRQ score
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Proportion of ACQ-6 responders
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Proportion of AIRQ responders
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Proportion of SGRQ responders
timeFrame: Baseline (Week 0), Week 24, Week 52
measure: Proportion of participants who require any systemic corticosteroid (SCS) use
timeFrame: Baseline period up to study Week 52
measure: Cumulative annualized SCS dose
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants who require longer-term (>30 consecutive days) SCS use
timeFrame: Baseline period up to study Week 52
measure: Number and type of asthma-related healthcare resource utilization (HRU)
timeFrame: Baseline period up to study Week 52
measure: Duration of asthma-related hospitalizations
timeFrame: Baseline period up to study Week 52
measure: AAER for asthma exacerbations (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants with asthma exacerbations (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Proportion of participants who completed the 52 -week study with any reduction in total number of asthma exacerbations (subgroups of participants)
timeFrame: Week 0 to Week 52
measure: Cumulative asthma exacerbation days (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Rate of asthma exacerbations associated with hospitalizations (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Rate of asthma exacerbations associated with emergency department urgent care (ED/UC) visits (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Number and type of asthma-related HRU (subgroups of participants)
timeFrame: Baseline period up to study Week 52
measure: Duration of asthma-related hospitalizations (subgroups of participants)
timeFrame: Baseline period up to study Week 52
Other outcomes:
measure: Number of participants with serious adverse events, adverse events that lead to tezepelumab treatment discontinuation, and adverse events of special interest
timeFrame: Week 0 to Week 52
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Westminster
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Upper Marlboro
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Ypsilanti
country: United States
facility: Research Site
state: Michigan
city: Saint Paul
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Hollis
country: United States
facility: Research Site
state: New York
city: Horseheads
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Valhalla
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Warwick
country: United States
facility: Research Site
state: Rhode Island
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Hendersonville
country: United States
facility: Research Site
state: Tennessee
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Vancouver
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: University of Michigan Health. Michigan, USA
name: Njira Lugogo., MD.
role: PRINCIPAL_INVESTIGATOR
References: