A Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients With Allergic Fungal Rhinosinusitis (AFRS)
Brief description: Primary Objective:
To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS)
Secondary Objectives:
To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24
To assess the efficacy of dupilumab to reduce the need for rescue treatments
To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS
To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS
To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS
To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS
To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses
To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS
To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS
To characterize the effect of dupilumab on total IgE and specific IgE
To assess immunogenicity to dupilumab in participants with AFRS
Detailed description: The duration of study for each participant will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.
Detailed description: The duration of study for each participant will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.