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).

Detailed Summary: The total study duration per patient is expected to be up to 68 weeks that will consist of a 4-week run-in period, 52-week treatment period, and a 12-week posttreatment period.
Sponsor: Sanofi

Current Primary Outcome:

  • Change from baseline in NC symptom severity score based on the patient daily morning assessment [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in NPS as assessed by nasal endoscopy [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in sinus opacifications as assessed by CT scans using Lund Mackay Score (For Japan only) [ Time Frame: From baseline to Week 24 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in TSS [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in University of Pennsylvania Smell Identification Test [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in severity of decreased/ loss of smell as assessed by the patient [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in sinus opacifications as assessed by CT scans using Lund Mackay Score (This endpoint will not be assessed as a secondary endpoint for Japan as it is already a co-primary endpoint). [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in in sinonasal outcome test-22 (SNOT-22) [ Time Frame: From baseline to Week 24 ]
  • Proportion of patients during study treatment receiving oral corticosteroid (OCS) for NP and/or planned to under surgery for nasal polyps [ Time Frame: 52 Weeks ]
  • Change from baseline in NC for q2w (Arm A) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  • Change from baseline in NPS for q2w (Arm A) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  • Change from baseline in NC for q2w/q4w (Arm B) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  • Change from baseline in NPS for q2w/q4w (Arm B) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: September 8, 2016
Date Started: November 2016
Date Completion: December 2018
Last Updated: May 11, 2017
Last Verified: May 2017