Last updated on August 2018

A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Brief description 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 polyp 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 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 patients requiring treatment with systemic 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 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 residual effect in follow up. - 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.

Detailed Study Description

The total study duration per patient is expected to be up to 52 weeks that will consist of a 4-week run-in period, 24-week treatment period, and a 24-week posttreatment period.

Clinical Study Identifier: NCT02912468

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Investigational Site Number 6430001
Saint-Petersburg, Russian Federation

Recruitment Status: Closed

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