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Monoclonal Antibodies

Tezepelumab for Asthma

Phase 3

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Methacholine PC20 ≤ 4 mg/mL OR ≥15% decrease in FEV1 during saline inhalation for sputum induction OR ≥15% improvement in FEV1 after bronchodilator during the screening period

Be older than 18 years old

Must not have

Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks

Treatment with anti-IgE, anti-IL-4, anti-IL-5, or anti-IL-13 targeted therapy currently or within three months prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks from randomization (week 0) to endpoint assessment (week 16)

Awards & highlights

Pivotal Trial

Summary

This trial will test if tezepelumab, a drug that blocks the protein TSLP, can improve asthma symptoms by reducing airway inflammation.

Who is the study for?

Adults over 18 with uncontrolled moderate-to-severe asthma, diagnosed at least a year ago. Participants must have certain levels of airway responsiveness or inflammation and have had at least one asthma exacerbation in the past year. Exclusions include recent vaccine recipients, heavy ex-smokers, pregnant individuals, those with metal implants incompatible with MRI, substance abusers, and patients on certain other biologic therapies.

What is being tested?

The trial is testing Tezepelumab's effect on lung function in asthmatic patients by comparing it to a placebo. It will use advanced imaging (hyperpolarized Xenon MRI) and CT scans to assess changes in airway structure and sputum tests for inflammation after treatment.

What are the potential side effects?

While not specified here, common side effects of drugs like Tezepelumab may include reactions at the injection site, headache, fatigue, and potential increased risk of infection due to immune system alteration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My asthma test shows I react strongly to certain triggers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a serious infection needing hospital care or antibiotics in the last month.

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I have not taken anti-IgE, anti-IL-4, anti-IL-5, or anti-IL-13 therapy in the last 3 months.

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I have smoked the equivalent of 10 packs a year or more but no longer smoke.

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I haven't had any vaccines or COVID in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks from randomization (week 0) to endpoint assessment (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks from randomization (week 0) to endpoint assessment (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks from randomization (week 0) to endpoint assessment (week 16) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pre-bronchodilator 129Xe MRI ventilation defect percent (VDP).

Secondary study objectives

Change in the CT airway lumen area.

Change in the CT airway wall area percentage.

Change in the CT airway wall area.

+5 more

Other study objectives

Change in ACQ-5 score.

Change in AQLQ score.

Change in FeNO.

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TezepelumabActive Control1 Intervention

Tezepelumab 210 mg subcutaneous injections every 4 weeks as an investigational drug. Sterile tezepelumab will be provided 110 mg/mL pre-filled vial, with a dose of 210 mg delivered by pre-filled syringe.

Group II: Matched placeboPlacebo Group1 Intervention

Sterile placebo for tezepelumab will be provided in identically matched pre-filled syringes.

0 / 5Eligibility criteria met