NCT05049122

Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Who Are Not Adequately Controlled With Existing Therapies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant): * Screening Period (2 to 4 weeks) * Intervention Period (up to 52 weeks±3 days)

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-12-21
• Completion: 2023-07-05
• First posted: 2021-09-17
• Last updated: 2025-09-11
• Results posted: 2024-01-22

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study