Efficacy and safety of tezepelumab in participants with CRSwNP
Research type
Research Study
Full title
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis (WAYPOINT)
IRAS ID
290321
Contact name
Claire Hopkins
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-003062-39
Duration of Study in the UK
2 years, 10 months, 15 days
Research summary
Astrazeneca are doing this study to learn more about the effect and safety of
tezepelumab when given to patients who have severe chronic rhinosinusitis with nasal polyposis in order to better understand the studied disease and associated health problems. To do this, tezepelumab will be compared with placebo. This research study is planned to last for up to 81 weeks and include around 400 randomised participants globally. The enrolment/run-in period will be approximately 5 weeks to allow adequate time for all the eligibility criteria to be evaluated. Participants who meet the eligibility criteria will be randomised and have a 50% chance of receiving either tezepelumab or placebo. All subjects will be given nasal spray to take throughout the study. After randomisation, participants will be treated at 4-week intervals for 48 weeks. The end-of-treatment (EOT) visit at week 52 will occur at 4 weeks after last treatment is administered. Approximately 200 of the first participants to enter the study will have a 24 weeks follow up period and the remaining participants will have a 12 weeks follow up period. Randomised participants will undergo tests such as physical exams, nasal endoscopy, CT scan, vital signs, ECG, safety blood/urine samples, collection of exploratory blood/urine samples, collection of nasal epithelial lining fluid, nasal swabs for bacterial culture and swab from the back of your nose or throat for COVID-19 testing. They will also be asked to complete questionnaires, smell test, test for nasal air flow and undergo lung function (for asthma patients only). Other tests which will be
performed as a sub study for a subset of subject will include the collection of blood sample and nasal biopsy. The study is anticipated to continue until May 2024.REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/1311
Date of REC Opinion
21 Jan 2021
REC opinion
Further Information Favourable Opinion