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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.
Must not have
Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), week 24, week 52
Awards & highlights

Summary

This trial tests an injectable medication called tezepelumab for people with severe asthma who need high doses of inhaled steroids and have frequent asthma attacks. The medication works by reducing inflammation in the airways to help improve breathing and decrease asthma attacks.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with severe COPD.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
AAER for asthma exacerbations (subgroups of participants)
Asthma Control Questionnaire (ACQ-6)
Asthma Impairment and Risk Questionnaire (AIRQ)
+29 more
Other study objectives
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%
Bronchitis bacterial
8%
Asthma
5%
Bronchitis
5%
Oral candidiasis
5%
Myalgia
4%
Headache
4%
Fall
3%
Hypertension
1%
Sinusitis
1%
Cardiac arrest
1%
Cardiac failure
1%
Supraventricular tachycardia
1%
Septic shock
1%
Incisional hernia
1%
Acute kidney injury
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Nephrolithiasis
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

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
4,358 Previous Clinical Trials
288,646,875 Total Patients Enrolled
345 Trials studying Asthma
660,566 Patients Enrolled for Asthma
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,741 Total Patients Enrolled
20 Trials studying Asthma
39,694 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
~95 spots leftby Jul 2025
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