NCT04678856

Dupilumab in CRSsNP

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo

Detailed description

The duration of study for each participant will include 2-4 weeks of screening period, 24-52 weeks randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.

Conditions

• Chronic Rhinosinusitis Without Nasal Polyps
• Sinusitis
• Chronic Sinusitis
• Sinus Disorder
• Respiratory Disorder

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form:Injection solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Timeline

• Start date: 2020-12-02
• Primary completion: 2023-11-14
• Completion: 2024-01-29
• First posted: 2020-12-22
• Last updated: 2025-02-10
• Results posted: 2024-12-18

Locations

58 sites across 13 countries: United States, Argentina, Belgium, Canada, Chile, China, Hungary, Portugal, Russia, South Korea, Spain, Sweden, Ukraine

Regulatory

• FDA-regulated drug study