Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT04684524. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients With Allergic Fungal Rhinosinusitis (AFRS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04684524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2020 (Actual)
- Primary completion
- Dec 14, 2024 (Actual)
- Completion
- Mar 7, 2025 (Actual)
- Last update posted
- Sep 3, 2026
2020 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400001 | Tampa | Florida | 33613 | — |
| Emory University Hospital Midtown Campus Site Number : 8400009 | Atlanta | Georgia | 30308 | — |
| Advanced ENT and Allergy Site Number : 8400004 | Louisville | Kentucky | 40220 | — |
| South Louisiana Ear, Nose, Throat and Facial Plastic Surgery Site Number : 8400019 | Mandeville | Louisiana | 70471 | — |
| National Allergy and Asthma Research, LLC Site Number : 8400002 | Charleston | South Carolina | 29407 | — |
| Vanderbilt University Medical Center Site Number : 8400013 | Nashville | Tennessee | 37232 | — |
| REX Clinical Trials Site Number : 8400017 | Beaumont | Texas | 77701-3713 | — |
| Ut- Houston Medical School Site Number : 8400010 | Houston | Texas | 77030 | — |
| USA Clinical Trials Site Number : 8400020 | San Antonio | Texas | 78229 | — |
| Alamo ENT Associates Site Number : 8400018 | San Antonio | Texas | 78258 | — |
| Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400008 | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04684524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Nov 15, 2026
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