NCT04684524

Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

A Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients With Allergic Fungal Rhinosinusitis (AFRS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Allergic Fungal Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form:Injection solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-14
• Completion: 2025-03-07
• First posted: 2020-12-24
• Last updated: 2025-12-22
• Results posted: 2025-12-22

Locations

47 sites across 9 countries: United States, Argentina, Canada, China, India, Israel, Japan, Saudi Arabia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study