Clinical Trial: An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
Brief Summary:
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score in comparison to placebo.
Secondary Objectives:
To evaluate effect of dupilumab with regards to:
- symptoms of sinusitis
- sinus Computed Tomography (CT) scan
- nasal polyp score in the sub-group of patients with co-morbid asthma
- Safety and tolerability
Detailed Summary:
Screening period (4 weeks) + Randomized Treatment Period (16 weeks)+ Post-Treatment Period (16 weeks) = 36 weeks.
To ensure at least 28 patients with co-morbid asthma needed for subgroup analysis, recruitment of NP patients without co-morbid asthma will stop when approximately 28 patients without asthma are randomized.
Sponsor: Sanofi
Current Primary Outcome: Change from baseline in endoscopic Nasal Polyp Score (NPS) [ Time Frame: 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in NPS in sub-group of co-morbid asthma [ Time Frame: 16 weeks ]
- Change from baseline in patient reported symptoms of sinusitis [ Time Frame: 16 weeks ]
- Change from baseline in nasal peak inspiratory flow [ Time Frame: 16 weeks ]
- Change from baseline in smell test [ Time Frame: 16 weeks ]
- Change from baseline in CT scan [ Time Frame: 16 weeks ]
- Time to first response in NPS [ Time Frame: 16 weeks ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: August 8, 2013
Date Started: August 2013
Date Completion:
Last Updated: November 3, 2015
Last Verified: November 2015
