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Monoclonal Antibodies

Tezepelumab for Severe Asthma (WAYFINDER Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years.
Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights

WAYFINDER Trial Summary

This trial will test whether Tezepelumab can help reduce oral steroid use in people with severe asthma, who are already taking them with or without other asthma medications.

Who is the study for?
Adults aged 18-80 with severe asthma, on long-term oral corticosteroids (5-40 mg of prednisone daily) for at least 3 months, and who've had an asthma exacerbation in the past year. Participants must have been on a stable steroid dose for 4 weeks prior to joining and treated with high-dose inhalers. Excluded are those with immunodeficiency, recent major surgery, other significant diseases or infections, drug abuse history within a year, previous tezepelumab use or participation in other trials.Check my eligibility
What is being tested?
The trial is testing Tezepelumab's effectiveness and safety in reducing the need for oral steroids in adults with severe asthma. It aims to see if this treatment can help manage asthma better than current standard therapies.See study design
What are the potential side effects?
Potential side effects of Tezepelumab may include reactions at the injection site, headaches, fatigue, and possible increased risk of infection due to its immune-modulating effects.

WAYFINDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been on daily steroids for asthma, between 5 and 40 mg, for the last 3 months.
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I am between 18 and 80 years old.
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I have been on high-dose asthma medication for at least 6 months.
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I have been on daily steroids for asthma, between 5mg and 40mg, for the last 3 months.
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I have been on a stable dose of oral corticosteroids for at least 4 weeks.
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I have had at least one asthma attack in the last year.

WAYFINDER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who discontinued OCS without loss of asthma control
Proportion of participants who reduced daily prescribed maintenance OCS dose to ≤ 5 mg/day without loss of asthma control
Secondary outcome measures
Absolute and percent change from baseline in daily maintenance OCS dose
Categorised percent reduction from baseline in the daily maintenance OCS dose
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score
+10 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078
16%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Asthma
8%
Bronchitis bacterial
5%
Myalgia
5%
Bronchitis
5%
Oral candidiasis
4%
Headache
4%
Fall
3%
Hypertension
1%
Cardiac failure
1%
Cataract
1%
Supraventricular tachycardia
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Septic shock
1%
Incisional hernia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Sinusitis
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

WAYFINDER Trial Design

1Treatment groups
Experimental Treatment
Group I: TezepelumabExperimental Treatment1 Intervention
Tezepelumab subcutaneous injection
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
4,259 Previous Clinical Trials
288,593,599 Total Patients Enrolled
328 Trials studying Asthma
639,331 Patients Enrolled for Asthma

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05274815 — Phase 3
Asthma Research Study Groups: Tezepelumab
Asthma Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT05274815 — Phase 3
Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274815 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this trial at any given time?

"Yes, as the listing on clinicaltrials.gov indicates, this study is recruiting patients. The trial was originally posted on May 17th, 2022 and has been edited most recently on November 4th of the same year. Currently, 8 different locations are looking for a total of 323 participants."

Answered by AI

Are there any participants needed for this clinical trial at the moment?

"Yes, the information on clinicaltrials.gov suggests that this study is recruiting patients as of the most recent update on 11/4/2022. The trial was first posted 5/17/2022 and is enrolling 323 participants between 8 locations."

Answered by AI

Who meets the requirements to be a test subject in this experiment?

"This trial is recruiting 323 participants who have asthma and are between the ages of 18 and 80. The following criteria must be met in order to be eligible for the study: - Age 18-80 years- Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1- Participant should be on a stable OCS dose for at least 4 weeks prior to Visit 1- Documented history of at least 1 asthma exacerbation event within 12 months prior"

Answered by AI

Could you please elaborate on the potential risks of Tezepelumab?

"Tezepelumab is a medication that has completed Phase 3 clinical trials. This means there is available data which supports its efficacy and multiple rounds of data supporting safety. Our team at Power estimates the safety of Tezepelumab to be a 3 on a scale from 1 to 3."

Answered by AI

Is this clinical trial happening at more than one hospital in the state?

"Currently, this trial is running at 8 sites. They are situated in Ann Arbor, Riverdale and Newark as well as 5 other locations. If you want to participate, it would be advantageous to choose the location nearest to you so that travelling isn't an inconvenience."

Answered by AI

For this particular test, is the age limit set at 45 years or above?

"Enrolment for this study is open to patients aged between 18-80 years old. There are 117 clinical trials available for minors and 202 for senior citizens."

Answered by AI

What goals does this research hope to achieve?

"The primary outcome that will be assessed at Week 52 is the percentage of patients who are able to reduce their daily maintenance oral corticosteroid dose to 5 mg/day or below without loss of asthma control. Additionally, researchers will also monitor the rate of hospitalization and emergency room visits due to exacerbations, as well as the overall number of exacerbations over the course of the trial."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
How old are they?
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Research Site: < 48 hours
~45 spots leftby Sep 2024