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

  • STATUS
    Recruiting
  • participants needed
    62
  • sponsor
    Sanofi
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Updated on 27 September 2023

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

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.

Details
Condition Allergic Fungal Rhinosinusitis
Age 6years or above
Treatment Placebo, Dupilumab SAR231893
Clinical Study IdentifierNCT04684524
SponsorSanofi
Last Modified on27 September 2023

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