Research Study

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
Principal Investigator 
Mark FitzGerald

Overview

Body Locations and Systems 
ClinicalTrials.gov# 
NCT02898454
Status 
Recruiting
Study Start/End 
Apr 1, 2017 to Dec 31, 2018
Locations 
Diamond Health Care Centre, Vancouver General Hospital
Name/Title 
Linda Hui, Research Nurse
Phone 
604-875-5697
Email Address 
linda.hui@ubc.ca
Purpose of Study 

Primary Objective:

To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses will be also a co-primary 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 patients requiring treatment with oral corticosteroids or NP surgery.

To evaluate the effect of dupilumab on patient reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).

To evaluate efficacy with various regimen.

To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [NERD]).

To evaluate the safety of dupilumab in patients with bilateral NP.

To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies (ADA).

Eligibility 

Visit ClinicalTrials.gov for more information. 

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.