NCT02898454

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: * To evaluate the efficacy of dupilumab in improving total symptoms score. * To evaluate the efficacy of dupilumab in improving sense of smell. * To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants). * To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. * To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. * To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. * To evaluate the safety of dupilumab in participants with bilateral NP. * To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.

Detailed description

The total study duration per participant was up to 68 weeks that consisted of a 4-weeks run-in period, 52-weeks treatment period, and a 12-weeks post treatment period.

Conditions

• Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893 (REGN668)	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Mometasone furoate nasal spray	Pharmaceutical form: Suspension Route of administration: Intranasal

Timeline

• Start date: 2016-11-28
• Primary completion: 2018-08-27
• Completion: 2018-11-16
• First posted: 2016-09-13
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

123 sites across 14 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Israel, Japan, Mexico, Portugal, Russia, Spain, Sweden, Turkey (Türkiye)