A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
Brief description: Primary Objective
-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell
Secondary Objectives
To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab
To evaluate the safety of dupilumab and omalizumab
Detailed description: Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.
Detailed description: Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.