NCT04851964

Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults with severe, chronic rhinosinusitis with nasal polyposis. Approximately 400 subjects will be randomized globally. Participants will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS) every 4 weeks, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12-24 weeks for participants who complete the 52-week treatment period. All participants will have background mometasone furoate nasal spray or equivalent intranasal corticosteroid at a stable dose from Visit 1 and throughout the screening and study period.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
BIOLOGICAL	Experimental: Tezepelumab	Tezepelumab subcutaneous injection
OTHER	Placebo	Placebo subcutaneous injection
DRUG	Mometasone furoate or equivalent intranasal corticosteroid	Background MFNS or equivalent INCS at stable dose

Timeline

• Start date: 2021-04-22
• Primary completion: 2024-09-23
• Completion: 2024-12-11
• First posted: 2021-04-21
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

112 sites across 10 countries: United States, Canada, China, Denmark, Germany, Hungary, Japan, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study