Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
Status:
Recruiting
Trial end date:
2023-11-21
Target enrollment:
Participant gender:
Summary
Primary Objective:
To evaluate the ability of dupilumab to reduce the need for rescue therapy with systemic
corticosteroids (SCS) or surgery of AFRS in patients with AFRS who previously have had
surgery for AFRS
Secondary Objectives:
To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a
population with allergic fungal rhinosinusitis (AFRS) 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 patients 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 patients 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 patients with AFRS To evaluate the
pharmacokinetics (PK) of dupilumab in patients with AFRS To characterize the effect of
dupilumab on total IgE and specific IgE To assess immunogenicity to dupilumab in patients
with AFRS