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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
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 belowSelect...
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:Select...
I have had a serious infection needing hospital care or antibiotics in the last month.
Select...
I have not taken anti-IgE, anti-IL-4, anti-IL-5, or anti-IL-13 therapy in the last 3 months.
Select...
I have smoked the equivalent of 10 packs a year or more but no longer smoke.
Select...
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)
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 moreOther study objectives
Change in ACQ-5 score.
Change in AQLQ score.
Change in FeNO.
+11 moreTrial 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.
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,613,211 Total Patients Enrolled
20 Trials studying Asthma
901 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had at least one worsening of my condition in the past year.My asthma test shows I react strongly to certain triggers.I have had a serious infection needing hospital care or antibiotics in the last month.I've had an asthma attack treated with steroids in the last 6 weeks.I have moderate or severe asthma and am on a specific asthma treatment plan.I have not taken anti-IgE, anti-IL-4, anti-IL-5, or anti-IL-13 therapy in the last 3 months.I was diagnosed with asthma over a year ago by a lung doctor.I have smoked the equivalent of 10 packs a year or more but no longer smoke.I haven't had any vaccines or COVID in the last 30 days.I have a lung condition that needed treatment in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Matched placebo
- Group 2: Tezepelumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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