NCT01920893

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (NPS) in comparison to placebo. Secondary Objectives: To evaluate effect of dupilumab with regards to: * symptoms of sinusitis, * sinus computed tomography (CT) scan, * NPS in the sub-group of participants with co-morbid asthma, * Safety and tolerability.

Detailed description

Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks. To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	Placebo (for dupilumab)	Solution for injection; Subcutaneous injection.
DRUG	Dupilumab	Solution for injection; Subcutaneous injection.
DRUG	Mometasone furoate nasal spray	Nasal spray, 2 actuations in each nostril twice daily.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-08-12
• Last updated: 2017-06-26
• Results posted: 2017-06-02

Locations

14 sites across 4 countries: United States, Belgium, Spain, Sweden