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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: Completed Phase 3 study of Allergic Fungal Rhinosinusitis, sponsored by Sanofi.
NCT04684524 is a Phase 3 study of Allergic Fungal Rhinosinusitis that has completed, run by Sanofi. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The LMK score is used to quantify the degree of opacification of each sinus on CT scan. The CT scan LMK staging system represents the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus plus the osteomeatal complex on each side). The extent of sinus opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacifi
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 |
What the finished NCT04684524 record still lists
NCT04684524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04684524's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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