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Monoclonal Antibodies

Tezepelumab for Severe Asthma (PASSAGE Trial)

Phase 4
Recruiting
Led By Njira Lugogo., MD.
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), week 24, week 52
Awards & highlights

PASSAGE Trial Summary

This trial will test the effectiveness and safety of tezepelumab in people with severe asthma, including people who have not been studied extensively in the United States.

Who is the study for?
This trial is for adults and adolescents (12 years or older) with severe asthma who've had at least 2 exacerbations in the past year, are on medium to high dose inhaler steroids plus another controller medication, and are under a specialist's care. They must be eligible for tezepelumab per US guidelines but not have used other biologics recently or be part of another asthma study.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of tezepelumab in treating severe asthma. It focuses on diverse populations within the United States that haven't been studied much before.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with drugs like tezepelumab include allergic reactions, injection site reactions, headache, fatigue, and potential worsening of existing conditions.

PASSAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a medium to high dose asthma treatment for at least a year.
Select...
I have had at least 2 asthma attacks in the last year.
Select...
I have had at least 2 asthma attacks in the last year.

PASSAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), week 24, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), week 24, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized asthma exacerbation rate (AAER)
Cumulative asthma exacerbation days
Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations
+1 more
Secondary outcome measures
AAER for asthma exacerbations (subgroups of participants)
Asthma Control Questionnaire (ACQ-6)
Asthma Impairment and Risk Questionnaire (AIRQ)
+29 more
Other outcome measures
Number of participants with serious adverse events, adverse events that lead to tezepelumab treatment discontinuation, and adverse events of special interest

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078
16%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Asthma
8%
Bronchitis bacterial
5%
Myalgia
5%
Bronchitis
5%
Oral candidiasis
4%
Headache
4%
Fall
3%
Hypertension
1%
Cardiac failure
1%
Cataract
1%
Supraventricular tachycardia
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Septic shock
1%
Incisional hernia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Sinusitis
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

PASSAGE Trial Design

1Treatment groups
Experimental Treatment
Group I: TezepelumabExperimental Treatment1 Intervention
Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~2120

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,270 Previous Clinical Trials
288,612,710 Total Patients Enrolled
328 Trials studying Asthma
639,234 Patients Enrolled for Asthma
ParexelIndustry Sponsor
304 Previous Clinical Trials
100,788 Total Patients Enrolled
20 Trials studying Asthma
39,695 Patients Enrolled for Asthma
Njira Lugogo., MD.Principal InvestigatorUniversity of Michigan Health. Michigan, USA

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05329194 — Phase 4
Asthma Research Study Groups: Tezepelumab
Asthma Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT05329194 — Phase 4
Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329194 — Phase 4
Asthma Patient Testimony for trial: Trial Name: NCT05329194 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for this experiment?

"Affirmative. The clinicaltrials.gov website states that this medical examination, which was initially published on April 29th 2022 and most recently modified on November 7th of the same year, is still seeking participants with 400 individuals required to take part in 34 different locations."

Answered by AI

What is the aggregate amount of participants taking part in this research?

"Affirmative, the information on clinicaltrials.gov confirms that enrollment for this medical study is still ongoing. The trial was initially published on April 29th 2022 and later modified on November 7th 2022; with a total of 400 patients required to be recruited from 34 different sites."

Answered by AI

Is it feasible for individuals under 60 years of age to join this research?

"The age criteria for this study requires all participants to be over the legal threshold of 18, and younger than 130 years old."

Answered by AI

Are there any associated risks with Tezepelumab treatments?

"Tezepelumab was awarded a score of 3 due to its approval as part of the fourth phase clinical trials, which implies prior data supports safety."

Answered by AI

What aim is this experiment aiming to achieve?

"According to the trial sponsor AstraZeneca, Proportion of participants with asthma exacerbations will be used as the primary outcome and measured over a Baseline period up to study Week 52. Secondary outcomes include Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1), which is determined via spirometry test; AAER for exacerbations resulting in hospitalization, ED visit or urgent care visit; and Proportion of pre-BD FEV1 responders who experience either 5% or 100 mL improvement from baseline."

Answered by AI

At what locations is this research trial taking place?

"Currently, 34 sites are signing up participants for this medical trial. These locations span from Hoover to Fort Worth and Hollis with many other cities included in between. To reduce strain on prospective patients, it is advisable to find the nearest site when enrolling."

Answered by AI

Who is eligible to join this clinical investigation?

"This clinical trial is looking for 400 asthma sufferers aged between 18 and 130 to partake. To be eligible, potential volunteers must have been taking a combination of medications prescribed by their doctor for at least 12 months in accordance with the Global Initiative for Asthma (GINA 2021) guidelines; had 2 exacerbations over that period; currently receive care from specialist physicians such as pulmonologists/ allergists; completed an approved course of COVID-19 vaccination 28 days before commencing tezepelumab treatment, and provided written informed consent."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Michigan
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I am interested in learning more about this trial. Having multiple flare ups exacerbation this past year no results of improving.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many visits are required and when do they happen?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
2022. "Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329194.
All > Pediatric Asthma > Asthma
~147 spots leftby Jul 2025
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