Nasal Polyps Clinical Trial
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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