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NCT04684524 · ClinicalTrials.gov registry record · Phase 3
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)
A Phase 3 study of Allergic Fungal Rhinosinusitis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT04684524 is a Phase 3 study of Allergic Fungal Rhinosinusitis that has completed, run by Sanofi. The registered enrollment target is 62 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT04684524, a Phase 3 study of Allergic Fungal Rhinosinusitis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893
Study Locations (20)
Other
- Investigational Site Number : 0320002 - Buenos Aires
- Investigational Site Number : 0320004 - Mendoza
- Investigational Site Number : 1560005 - Beijing
- Investigational Site Number : 1560001 - Beijing
- Investigational Site Number : 1560004 - Changsha
Texas
- REX Clinical Trials Site Number : 8400017 - Beaumont
- Ut- Houston Medical School Site Number : 8400010 - Houston
- USA Clinical Trials Site Number : 8400020 - San Antonio
- Alamo ENT Associates Site Number : 8400018 - San Antonio
Buenos Aires
- Investigational Site Number : 0320003 - CABA
- Investigational Site Number : 0320001 - CABA
Florida
- Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400001 - Tampa
Georgia
- Emory University Hospital Midtown Campus Site Number : 8400009 - Atlanta
Kentucky
- Advanced ENT and Allergy Site Number : 8400004 - Louisville
Louisiana
- South Louisiana Ear, Nose, Throat and Facial Plastic Surgery Site Number : 8400019 - Mandeville
South Carolina
- National Allergy and Asthma Research, LLC Site Number : 8400002 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04684524
The ClinicalTrials.gov registry entry for NCT04684524 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Allergic Fungal Rhinosinusitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04684524 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Texas, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT04684524 about?
NCT04684524 is a clinical study titled "Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)". 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 allerg...
What is the current status of trial NCT04684524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2020-12-01. Estimated completion is 2025-03-07.
What conditions does trial NCT04684524 study?
This clinical trial studies the following conditions: Allergic Fungal Rhinosinusitis.
What interventions are being tested in trial NCT04684524?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (DRUG).
Who is sponsoring clinical trial NCT04684524?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04684524 being conducted?
This trial has 20 study locations across Florida, Georgia, Kentucky, Louisiana, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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