MedTrace Logo

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

NCT04851964 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-01-27

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Brian Lipworth, MD · University of Dundee

  • Joseph K Han, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2024-09-23
Completion
2024-12-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Denmark
  • Germany
  • Hungary
  • Japan
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851964 on ClinicalTrials.gov