Clinical Trial: Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Int

Brief Summary:

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).