NCT02912468

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective. Secondary Objectives: * To evaluate the efficacy of dupilumab in improving total symptoms score (TSS). * 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 Japan). * To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery. * To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22). * To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]). * To evaluate residual effect in follow up. * 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 expected to be up to 52 weeks that consisted of a 4-weeks run-in period, 24-weeks treatment period, and a 24-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 50 micrograms	Pharmaceutical form: Suspension (Nasal spray) Route of administration: Intranasal

Timeline

• Start date: 2016-12-05
• Primary completion: 2018-07-05
• Completion: 2018-07-05
• First posted: 2016-09-23
• Last updated: 2019-07-25
• Results posted: 2019-07-25

Locations

76 sites across 13 countries: United States, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russia, Ukraine, United Kingdom