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

NCT04851964 ↗

Phase 3 Completed 416 enrolled AstraZeneca Amgen · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2021-04-22
Primary completion: 2024-09-23
Completion: 2024-12-11

Outcome

Met primary endpoint

registry analysis (superiority test); Tezepelumab vs Placebo; p <.0001; Difference in Least Squares Means -2.078 (95% CI -2.399 to -1.757); ANCOVA NCT04851964 ↗

registry analysis (superiority test); Tezepelumab vs Placebo; p <.0001; Difference in Least Squares Means -1.039 (95% CI -1.214 to -0.865); ANCOVA NCT04851964 ↗

release “the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE ® (tezepelumab-ekko) significantly reduced nasal polyp severity” amgen.com ↗

Publications

Lipworth BJ, Han JK, Desrosiers M, Hopkins C, Lee SE, Mullol J, Pfaar O, Li T, Chen C, Almqvist G, Margolis MK, McLaren J, Jagadeesh S, MacKay J, Megally A, Hellqvist A, Mankad VS, Bahadori L, Ponnarambil SS; WAYPOINT Study Investigators. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2025 Mar 27;392(12):1178-1188. doi: 10.1056/NEJMoa2414482. Epub 2025 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tezepelumab	Monoclonal antibody	210 mg	Subcutaneous
Background	Mometasone furoate	Other / unclassified	—	Intranasal