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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks from randomization (week 0) to endpoint assessment (week 16)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pre-bronchodilator 129Xe MRI ventilation defect percent (VDP).
Secondary outcome measures
Change in the CT airway lumen area.
Change in the CT airway wall area percentage.
Change in the CT airway wall area.
+5 moreOther outcome measures
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
884 Previous Clinical Trials
2,598,286 Total Patients Enrolled
19 Trials studying Asthma
889 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Tezepelumab received official government sanction for use?
"There is a fair amount of data supporting both the efficacy and safety of Tezepelumab, as this is a Phase 3 trial. We've given it a score of 3."
Answered by AI
Could you provide more information about the sign-up process for this clinical trial?
"No, this particular study is not looking for new participants as of now. According to the information on clinicaltrials.gov, the study was posted on May 1st, 2022 and was last edited on May 16th, 2022. However, there are 322 other clinical trials that are still recruiting patients."
Answered by AI
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