Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)

Summary

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

Timeline

Start

2020-12-01

Primary completion

2024-12-14

Completion

2025-03-07

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Dupilumab; p <0.0001; Least squares (LS) Mean Difference -7.36 (95% CI -9.38 to -5.35); ANCOVA NCT04684524 ↗

Publications

• Luong AU, Levy JM, Wise SK, Han JK, Yoshikawa M, Zhang L, Schlosser R, Ranganathan P, Dakin P, Maloney J, Yancopoulos GD, Fontenot AP, Phadke NA, Robinson LR. Dupilumab for patients with allergic fungal rhinosinusitis. J Allergy Clin Immunol. 2026 Jul 24:S0091-6749(26)00522-1. doi: 10.1016/j.jaci.2026.07.006. Online ahead of print.

Drugs

Indications