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Monoclonal Antibodies

Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps (WAYPOINT Trial)

Phase 3
Waitlist Available
Led By Brian Lipworth, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented treatment of nasal polyposis exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 and/or any history of NP surgery (or contraindications/intolerance to)
Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 52 weeks
Awards & highlights

WAYPOINT Trial Summary

This trial is testing the efficacy and safety of tezepelumab in people with severe chronic rhinosinusitis with nasal polyposis.

Who is the study for?
This trial is for people with severe chronic rhinosinusitis and nasal polyps, who've had symptoms like runny nose or loss of smell for over 8 weeks. They should have a history of sinus issues needing steroids or surgery but haven't used certain meds in the last 3 months. Those recently vaccinated for COVID-19 or with other serious lung conditions can't join.Check my eligibility
What is being tested?
The study tests Tezepelumab's effectiveness and safety against a placebo in participants with severe sinus issues due to nasal polyps. It's randomized, meaning participants are put into the Tezepelumab or placebo group by chance, and double-blind so neither doctors nor patients know who gets what.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include injection site reactions, headache, fatigue, and potential worsening of existing allergies or asthma. Participants will be monitored closely for any adverse reactions.

WAYPOINT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
My nose problem is severe enough to need surgery, based on a specific test score.

WAYPOINT Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Nasal Polyp-Quality of Life Compared with Placebo
Nasal Polyposis Surgery and/or Receiving Systemic Corticosteroids for Nasal Polyposis
Nasal Polyposis Symptom Diary Total Symptom Score
+1 more
Other outcome measures
Asthma Control in Participants with Comorbid Asthma and Aspirin Exacerbated Respiratory Disease (AERD)/Nonsteroidal Anti-Inflammatory Drug Exacerbated Respiratory Disease (NSAID-ERD)
Immunogenicity anti-drug antibodies
Loss of Smell
+7 more

Side effects data

From 2020 Phase 3 trial • 1061 Patients • NCT03347279
21%
Nasopharyngitis
11%
Upper respiratory tract infection
8%
Headache
5%
Bronchitis bacterial
5%
Bronchitis
4%
Urinary tract infection
4%
Back pain
4%
Sinusitis
4%
Arthralgia
4%
Influenza like illness
4%
Hypertension
3%
Rhinitis allergic
3%
Gastroenteritis
3%
Rhinitis
3%
Pharyngitis
3%
Viral upper respiratory tract infection
3%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tezepelumab 210mg Q4W

WAYPOINT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TezepelumabExperimental Treatment1 Intervention
Tezepelumab subcutaneous injection, in an accessorized pre-filled syringe.
Group II: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection, in an accessorized pre-filled syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental: Tezepelumab
2020
Completed Phase 3
~1110

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,486 Total Patients Enrolled
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,272 Total Patients Enrolled
Brian Lipworth, MDPrincipal InvestigatorUniversity of Dundee
6 Previous Clinical Trials
89 Total Patients Enrolled

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04851964 — Phase 3
Chronic Rhinosinusitis Research Study Groups: Tezepelumab, Placebo
Chronic Rhinosinusitis Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT04851964 — Phase 3
Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851964 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
Oklahoma
Other
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis
2021. "Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04851964.
~51 spots leftby Oct 2024
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