NCT05878093

Dupilumab in Chinese Adult Participants With CRSwNP

A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray). Study details include: * The study duration will be up to 40 weeks. * The treatment duration will be up to 24 weeks. * The number of visits will be 7.

Detailed description

up to 40 weeks

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	Dupilumab	solution for subcutaneous injection
DRUG	Placebo	solution for subcutaneous injection
DRUG	Budesonide	nasal spray (suspension)

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-09-06
• Completion: 2024-11-28
• First posted: 2023-05-26
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

18 sites across 1 country: China

Regulatory

• FDA-regulated drug study