18 and older, any sex, with Allergic Fungal Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Oral/Topical Corticosteroid Utilization Per ParticipantPrimary· Baseline and End of Treatment at Week 52
The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral corticosteroids rescue treatment.
Baseline
Group
Value
95% CI
Dupilumab
3
Placebo
2
Week 12
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 24
Group
Value
95% CI
Dupilumab
0
Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival CurvesSecondary· Up to End of Treatment at Week 52
Documentation of the number of revision sinus surgery per participant, that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS)
Group
Value
95% CI
Dupilumab
0
± 0
Placebo
0
± 0
Endoscopic Nasal Polyp Score (NPS)Secondary· Baseline and End of Treatment at Week 52
NPS is a physician-reported tool to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 (no polyps visible) to 4 (massive polyposis completely obstructing the nasal cavity), with the total score being the sum of left and right nostril scores (range: 0-8). The total NPS is the sum of scores from the right and left nostrils.
Baseline
Group
Value
95% CI
Dupilumab
4.33
± 0.47
Placebo
5
± 1
Week 12
Group
Value
95% CI
Dupilumab
1
± 0
Placebo
0
± 0
Week 24
Group
Value
95% CI
Dupilumab
2
± 0
Percent Predicted Forced Vital Capacity (%FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%)Secondary· Baseline and End of Treatment at Week 52
Spirometry is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales, and how quickly the participant exhales. Forced vital capacity (FVC) refers to the maximal volume of air that can be expired following maximum inspiration. It is the total of tidal volume, inspiratory reserve volume, and expiratory reserve volume. The percent FVC is the FVC compared to a predicted FVC based on age, sex, and height.
Baseline
Group
Value
95% CI
Dupilumab
107
± 3
Placebo
104
± 0
Forced Expiratory Volume in 1 Second (FEV1) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%)Secondary· Baseline and End of Treatment at Week 52
Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from the lungs in one second.
Baseline
Group
Value
95% CI
Dupilumab
3.55
± 0.76
Placebo
2.80
± 0
Forced Vital Capacity (FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%)Secondary· Baseline and End of Treatment at Week 52
Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test.
Baseline
Group
Value
95% CI
Dupilumab
4.67
± 1.07
Placebo
3.53
± 0
FEV1/FVC Ratio Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%)Secondary· Baseline and End of Treatment at Week 52
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age-dependent, values less than 0.70 are suggestive of airflow limitation with an obstructive pattern.
Baseline
Group
Value
95% CI
Dupilumab
0.76
± 0.01
Placebo
0.79
± 0
The 22-item Sinonasal Outcomes Test (SNOT-22) ScoreSecondary· 52 weeks and 64 weeks
The SNOT-22 score is a validated disease-specific questionnaire quantifying the quality of life among participants with chronic rhinosinusitis. The individual question scores range from 0 (no problem) to 4 (as bad as it can be) among 22 separate questions. Scoring 0 to 110. Higher scores = more severe symptoms and poorer quality of life.
Baseline
Group
Value
95% CI
Dupilumab
37
± 14.73
Placebo
17
± 5.66
Week 12
Group
Value
95% CI
Dupilumab
13
± 0
Placebo
2
± 0
Week 24
Group
Value
95% CI
Dupilumab
12
± 0
Change in Asthma Control Questionnaire (ACQ) Score Among Participants With AsthmaSecondary· 52 weeks and 64 weeks
The Asthma Control Questionnaire (ACQ) is a validated, self-administered survey used to assess a participants' perception of disease control over the preceding week using Likert scale responses with a range of 0 (well controlled) to 6 (extremely poorly controlled). The ACQ consists of 7 items surveying the frequency of asthma related symptoms, the need for rescue medications, and perceived control of disease. The items are equally weighted and the ACQ score is the mean of the 7 items. Total scores range from 0 to 6 with lower scores indicating better control of asthma symptoms. A score change
Baseline
Group
Value
95% CI
Dupilumab
5.5
± 0.5
Placebo
6
± 0
Prevalence of Oral/Topical Corticosteroid Utilization Per Treatment CohortSecondary· 52 weeks and 64 weeks
The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral corticosteroid rescue treatment due to worsening signs and/or symptoms.
Baseline
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 12
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 24
Group
Value
95% CI
Dupilumab
0
Incidence of Oral/Topical Antibiotic Utilization Per ParticipantSecondary· 52 weeks and 64 weeks
The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral/topical antibiotic rescue treatment.
Baseline
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 12
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 24
Group
Value
95% CI
Dupilumab
0
Prevalence of Oral/Topical Antibiotic Utilization Per Treatment CohortSecondary· 52 weeks and 64 weeks
The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral/topical antibiotic rescue treatment due to worsening signs and/or symptoms.
Baseline
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 12
Group
Value
95% CI
Dupilumab
0
Placebo
0
Week 24
Group
Value
95% CI
Dupilumab
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Information on adverse events was collected beginning at run-in (Week -6) and continued through the final assessment at Week 24 until the study premature termination..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to find a more effective treatment for allergic fungal rhinosinusitis (AFRS). Most people suffering from nasal polyps have elevated levels of white blood cells called eosinophils that are involved in inflammation of the air passages. Despite appropriate treatment with oral/topical corticosteroids, saline irrigations, and surgery, nasal polyps return frequently within months of surgery. Participants will be administered a placebo or dupilumab every two weeks for 52 weeks.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 8 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05545072.