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Monoclonal Antibodies

Tezepelumab for Severe Asthma (PASSAGE Trial)

Phase 4

Waitlist Available

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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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

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I have been on a medium to high dose asthma treatment for at least a year.

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I have had at least 2 asthma attacks in the last year.

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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:

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I have been diagnosed with severe COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), week 24, week 52

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