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

NCT04684524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-12-22

Study results available
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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

Conditions

  • Allergic Fungal Rhinosinusitis

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-14
Completion
2025-03-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • China
  • India
  • Israel
  • Japan
  • Saudi Arabia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684524 on ClinicalTrials.gov