Trial · NCT04684524

Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)

NCT04684524, Phase 3, Completed, Sanofi; results first posted 2025-12-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dupilumab in Allergic Fungal Rhinosinusitis (AFRS). Trials, record NCT04684524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04684524

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
NCT number: NCT04684524
Status: Completed
Phases: Phase 3
Enrollment: 62 participants, actual
Lead sponsor: Sanofi
Conditions: Allergic Fungal Rhinosinusitis
Interventions: Dupilumab SAR231893, Placebo
First posted: 2020-12-24
Last updated: 2026-09-03
Other registries' IDs: eudract:2020-002999-12
Results first posted: 2025-12-22

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Baseline (Day 1) and Week 52	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 opacification. In addition, the osteomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is 12 per side; total score ranges from 0 (normal) to 24 (more opacified) corresponding to the sum of all sinuses and the osteomeatal complexes bilaterally. Higher score indicate worse outcome; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Secondary	Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The nasal symptom diary is designed to assess the severity of chronic rhinosinusitis (CRS) nasal symptoms on daily basis. Score range: 0 = no symptoms, 1 = mild symptoms (symptoms clearly present, but minimal awareness and easily tolerated), 2= moderate symptoms (definite awareness of symptoms that is bothersome but tolerable) and 3 = severe symptoms (symptoms that are hard to tolerate, cause interference with activities or daily living). Higher scores denote greater symptom severity; a negative change from baseline indicate improvement. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
Secondary	Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS)	Baseline (Day 1) and Week 24	The bilateral endoscopy NPS is determined by the clinician who assesses nasal polyp formation. Polyps on each side of the nose are graded based on polyp size; scores: 0 = no polyps; 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = polyps reaching below the lower border of the middle turbinate; 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate and 4 = large polyps causing complete obstruction. The total score is the sum of the right and left nostrils, ranging from 0 (no obstruction) to 8 (complete obstruction); higher score indicating worse outcome; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Secondary	Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Baseline (Day 1) and Week 24	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 opacification. In addition, the osteomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is 12 per side; total score ranges from 0 (normal) to 24 (more opacified) corresponding to the sum of all sinuses and the osteomeatal complexes bilaterally. Higher score indicate worse outcome; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Secondary	Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The nasal symptom diary is designed to assess the severity of CRS nasal symptoms on daily basis. The TSS is a composite score consisting of the sum of the following symptoms assessed daily in the morning: nasal congestion/obstruction, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge). Each of the individual items were scored from 0 = no symptoms to 3 = severe symptoms. TSS is the sum of individual items and ranges between 0 = no symptoms and 9 = severe symptoms. Higher scores on the TSS indicate greater symptom severity; a negative change from baseline indicate improvement. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
Secondary	Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT)	Baseline (Day 1) and Week 24	The UPSIT (UPSIT 40 odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of 4 booklets, each containing 10 odorants with 1 odorant per page. Above each odorant strip is a multiple-choice question with 4 alternative words to describe the odor and the participant is asked to indicate which word best describes the odor. Each smell has a possible of 4 answers with one being correct, therefore the potential total scores can range from 0 (worst possible score) to 40 (best possible score), with 1 point being awarded for each correctly identified odor. Scores of \<=18 were classified as anosmia, 19 to 25 as severe microsmia, 26 to 30 as moderate microsmia, 31 to 34 as mild microsmia, and 35 to 40 as normal smell appreciation. Higher scores indicated better olfactory function; i.e. better sense of smell. Baseline was defined as the last available value before the first dose of study drug.
Secondary	Change From Baseline to Week 24 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The nasal symptom diary is designed to assess the severity of CRS nasal symptoms on daily basis. Decreased/loss of smell is scored as: 0 = no symptoms, 1 = mild symptoms (symptoms clearly present, but minimal awareness and easily tolerated), 2= moderate symptoms (definite awareness of symptoms that is bothersome but tolerable) and 3 = severe symptoms (symptoms that are hard to tolerate, cause interference with activities or daily living). Higher scores denote greater symptom severity; a negative change from baseline indicate improvement. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
Secondary	Change From Baseline to Week 52 in Endoscopy NPS	Baseline (Day 1) and Week 52	The bilateral endoscopy NPS is determined by the clinician who assesses nasal polyp formation. Polyps on each side of the nose are graded based on polyp size; scores: 0 = no polyps; 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = polyps reaching below the lower border of the middle turbinate; 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate and 4 = large polyps causing complete obstruction. The total score is the sum of the right and left nostrils, ranging from 0 (no obstruction) to 8 (complete obstruction); higher score indicating worse outcome; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Secondary	Change From Baseline to Week 52 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 52	The nasal symptom diary is designed to assess the severity of CRS nasal symptoms on daily basis. Score range: 0 = no symptoms, 1 = mild symptoms (symptoms clearly present, but minimal awareness and easily tolerated), 2= moderate symptoms (definite awareness of symptoms that is bothersome but tolerable) and 3 = severe symptoms (symptoms that are hard to tolerate, cause interference with activities or daily living). Higher scores denote greater symptom severity; a negative change from baseline indicate improvement. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
Secondary	Change From Baseline to Week 52 in 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score	Baseline (Day 1) and Week 52	The SNOT-22 is a validated questionnaire designed to assess the impact of CRS on participants health-related quality of life (HRQoL) and has 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of CRS. The recall period is past 2 weeks. Each item is rated on a 6-point Likert scale; response options ranging from 0 = no problem to 5 = problem as bad as it can be. A global score ranging from 0 (no impact) to 110 (severe impact) is calculated by summing the responses to all items; higher score indicates greater rhinosinusitis-related health burden; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Baseline (Day 1) and Week 52	The intent-to-treat (ITT) population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS)	Baseline (Day 1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Baseline (Day 1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT)	Baseline (Day 1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 24	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 52 in Endoscopy NPS	Baseline (Day 1) and Week 52	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 52 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Baseline (Day -7 to Day -1) and Week 52	The ITT population included all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 52 in 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score	Baseline (Day 1) and Week 52	The ITT population included all randomized participants. Only those participants with data collected at baseline and Week 52 are reported.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Placebo	-1.81	Standard Error 0.81	score on a scale
Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Dupilumab	-9.17	Standard Error 0.74	score on a scale
Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Placebo	-0.43	Standard Error 0.13	score on a scale
Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary	Dupilumab	-1.30	Standard Error 0.11	score on a scale
Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS)	Placebo	-0.80	Standard Error 0.38	score on a scale
Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS)	Dupilumab	-3.16	Standard Error 0.34	score on a scale
Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Placebo	-1.93	Standard Error 0.82	score on a scale
Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score	Dupilumab	-7.38	Standard Error 0.80	score on a scale
Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary	Placebo	-1.26	Standard Error 0.35	score on a scale
Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary	Dupilumab	-3.45	Standard Error 0.31	score on a scale

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	29
Overall Study	STARTED	Dupilumab	33
Overall Study	Randomized and Treated	Placebo	28
Overall Study	Randomized and Treated	Dupilumab	33
Overall Study	COMPLETED	Placebo	21
Overall Study	COMPLETED	Dupilumab	29
Overall Study	NOT COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Dupilumab	4

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Covid-19	Infections and infestations	Placebo	4	28	4
other	Covid-19	Infections and infestations	Dupilumab	5	33	5
other	Suspected Covid-19	Infections and infestations	Placebo	0	28	0
other	Suspected Covid-19	Infections and infestations	Dupilumab	2	33	2
other	Headache	Nervous system disorders	Placebo	0	28	0
other	Headache	Nervous system disorders	Dupilumab	2	33	2
other	Allergic Fungal Rhinosinusitis	Respiratory, thoracic and mediastinal disorders	Placebo	6	28	7
other	Allergic Fungal Rhinosinusitis	Respiratory, thoracic and mediastinal disorders	Dupilumab	1	33	1
other	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo	2	28	4
other	Asthma	Respiratory, thoracic and mediastinal disorders	Dupilumab	0	33	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	28
Total, all-cause mortality	Dupilumab	0	33
Total, other adverse events	Placebo	15	28
Total, other adverse events	Dupilumab	16	33
Total, serious adverse events	Placebo	3	28
Total, serious adverse events	Dupilumab	0	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42498125	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dupilumab vs Placebo: deaths from any cause	Trial comparisons
Dupilumab vs Placebo: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to Dupilumab	Trial comparisons
Dupilumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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