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Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps (WAYPOINT Trial)
WAYPOINT Trial Summary
This trial is testing the efficacy and safety of tezepelumab in people with severe chronic rhinosinusitis with nasal polyposis.
WAYPOINT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowWAYPOINT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 1061 Patients • NCT03347279WAYPOINT Trial Design
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Who is running the clinical trial?
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- I received a COVID-19 vaccine at least 28 days before my treatment starts.I do not regularly use decongestants, except for endoscopic procedures.I have been on a stable treatment for nasal polyps for 30 days.I haven't taken any immunosuppressive drugs in the last 3 months.I've been treated for nasal polyps with steroids or had surgery for it in the last year, but not in the last 3 months.Your SNOT-22 total score is 30 or higher at the first screening visit.I have had a runny nose or lost my sense of smell for more than 8 weeks.I have been diagnosed with chronic sinusitis with nasal polyps for over a year.My nose problem is severe enough to need surgery, based on a specific test score.I have no major health issues affecting my lungs except for asthma.I have not had sinus surgery in the last 6 months or any that altered the side wall of my nose.You have tested positive for COVID-19 or have symptoms of COVID-19.You have moderate to severe stuffy or blocked nose at the first visit.
- Group 1: Tezepelumab
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this trial taking place in multiple locations across Canada?
"29 different medical sites are currently recruiting patients for this study. In addition to Trois-Rivières, Louisville and Colorado Springs, there are 26 other locations where patients can enroll. To reduce travel time and related costs, patients are encouraged to select the closest participating clinic."
Are there any openings in this clinical trial for new patients?
"Yes, the trial is still ongoing and actively recruiting patients. It was first posted on 4/22/2021, as indicated by the clinicaltrials.gov website, and the most recent update was on 8/4/2022. They are looking for 400 patients in 29 different locations."
Are there previous studies that have used tezepelumab?
"Tezepelumab was first trialled in 2019. To date, there have been 18,246 completed studies and 4 ongoing studies. Many of these studies are conducted in Trois-Rivières, Quebec."
Have similar tests been conducted in the past?
"Amgen's experimental drug, Tezepelumab, is being trialed in 127 cities and 17 countries. As of 2019, 396 patients have completed Phase 3 of the drug approval process. 18246 studies have been conducted in total."
How many people are allowed to be enrolled in this trial at one time?
"That is correct, according to the clinicaltrials.gov website, this trial is still looking for participants. The posting dates indicate that the trial was first advertised on 4/22/2021 and was most recently updated on 8/4/2022. They are looking for 400 individuals to take part in the trial at 29 different locations."
Has Tezepelumab received FDA approval for general use?
"There is both efficacy and safety data from past clinical trials supporting the use of Tezepelumab, so our team gave it a score of 3."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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