A Phase 3 interventional study of Dupilumab SAR231893 and Placebo in Allergic Fungal Rhinosinusitis, sponsored by Sanofi. Completed at 47 sites in 9 countries. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
The duration of study for each participant will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.
Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent.
Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all):
Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader:
AFRS patients with the following:
Body weight ≥15 kg
Exclusion Criteria:
Patients who have taken:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dupilumab administered every 2 or 4 weeks based on weights
Drug: Dupilumab SAR231893
Placebo administered every 2 or 4 weeks based on weights
Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score
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.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 24
Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS)
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.
Time frame: Baseline (Day 1) and Week 24
Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score
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.
Time frame: Baseline (Day 1) and Week 24
Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 24
Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT)
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.
Time frame: Baseline (Day 1) and Week 24
Change From Baseline to Week 24 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 24
Change From Baseline to Week 52 in Endoscopy NPS
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.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline to Week 52 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 52
Change From Baseline to Week 52 in 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score
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.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline to Week 52 in Three-dimensional CT Total Volume Occupied by Disease in All Sinuses
This method is used to calculate the percent occupied by disease. It is performed at locations including ethmoid sinus, frontal sinus, maxillary sinus, and sphenoid sinus. The total volume occupied by disease in all sinuses is reported here. For the analysis, central reading at baseline was used for comparison with Week 52 reading. It is graded on a scale of 0-100%; a higher score is worse and indicates greater volume occupied by disease. A negative change from baseline indicated improvement. Baseline was defined as the last available value before the first dose of study drug.
Time frame: Baseline (Day 1) and Week 52
Percentage of Participants Who Received Systemic Corticosteroids (SCS) and/or Underwent or Planned to Undergo Surgery for Allergic Fungal Rhinosinusitis (AFRS) at Week 52
SCS use was defined as the use of SCS for rescue treatment of AFRS or for another reason and was captured by the Investigator (or designee) in electronic case report form (eCRF). Participants who underwent or planned to undergo surgery for AFRS were also recorded in eCRF.
Time frame: Week 52
Change From Baseline to Week 24 in SNOT-22 Total Score
The SNOT-22 is a validated questionnaire designed to assess the impact of CRS on participants 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.
Time frame: Baseline (Day 1) and Week 24
Percent Change From Baseline in Serum Total Immunoglobulin-E (IgE) to Week 52
Blood samples were collected at specified timepoints for the assessment of IgE. Total IgE was measured with a quantitative method approved for diagnostic testing; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline to Weeks 24 and 52 in the Monthly Average Rhinorrhea Score From the Nasal Symptom Diary
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. Severity of rhinorrhea (average of anterior \[runny nose\]/posterior nasal discharge \[post-nasal drip\]) is presented here. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
Time frame: Baseline (Day -7 to Day -1) and Weeks 24 and 52
Change From Baseline to Week 52 in Monthly Average TSS Derived From the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 52
Change From Baseline to Weeks 24 and 52 in Visual Analog Scale (VAS) Rhinosinusitis
The rhinosinusitis VAS is used to evaluate the overall severity of the rhinosinusitis. It is a recommended scale to determine the participant's disease severity and to guide the treatment for CRS. The participant is asked to answer the following question: "How troublesome are your symptoms of your rhinosinusitis" on a 10-centimeter VAS from 0 = not troublesome to 10 = worst thinkable troublesome. Based on their score on the VAS, the severity of rhinosinusitis is divided into 3 categories as follows: mild = VAS 0 to 3, moderate = VAS \>3 to 7 and severe = VAS \>7 to 10; 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.
Time frame: Baseline (Day 1) and Weeks 24 and 52
Change From Baseline to Week 52 in UPSIT
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.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline to Week 52 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary
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.
Time frame: Baseline (Day -7 to Day -1) and Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.
Time frame: From first dose of study drug (Day 1) up to end of follow-up per participant, up to approximately 64 weeks
Serum Concentration of Dupilumab Over Time
Blood samples were collected at the specified timepoints to obtain serum concentration of dupilumab.
Time frame: Baseline (Day 1) and Weeks 12, 24 and 52
Percent Change From Baseline in Fungal-specific IgE at Week 52
Blood samples were collected at specified timepoints for the assessment of fungal-specific IgE which was measured with a quantitative method approved for diagnostic testing; a negative change from baseline indicated improvement. Baseline was defined as the last available value before the first dose of study drug.
Time frame: Baseline (Day 1) and Week 52
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to Dupilumab
Plasma samples were collected to evaluate antibodies to dupilumab. Treatment-emergent ADA responses were defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing.
Time frame: From first dose of study drug (Day 1) up to end of follow-up per participant, up to approximately 64 weeks
This study was conducted at 45 centers in 9 countries. A total of 152 participants were screened from 01-Dec-2020 to 28-Nov-2023 of which 90 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
| Milestone | Placebo | Dupilumab |
|---|---|---|
| Started | 29 | 33 |
| Randomized and treated | 28 | 33 |
| Completed | 21 | 29 |
| Not completed | 8 | 4 |
| Withdrew: Other | 2 | 0 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Adverse event | 1 | 1 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score | -1.81 ± 0.81 | -9.17 ± 0.74 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary | -0.43 ± 0.13 | -1.30 ± 0.11 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in Endoscopy Nasal Polyp Score (NPS) | -0.80 ± 0.38 | -3.16 ± 0.34 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score | -1.93 ± 0.82 | -7.38 ± 0.80 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in Monthly Average Total Symptom Score (TSS) Derived From the Nasal Symptom Diary | -1.26 ± 0.35 | -3.45 ± 0.31 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT) | 4.41 ± 1.71 | 8.87 ± 1.60 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary | -0.39 ± 0.16 | -1.28 ± 0.15 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Endoscopy NPS | -0.55 ± 0.43 | -3.32 ± 0.39 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Monthly Average Nasal Congestion/Obstruction Score From the Nasal Symptom Diary | -0.17 ± 0.15 | -1.57 ± 0.14 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score | -12.64 ± 4.06 | -29.94 ± 3.75 |
This method is used to calculate the percent occupied by disease. It is performed at locations including ethmoid sinus, frontal sinus, maxillary sinus, and sphenoid sinus. The total volume occupied by disease in all sinuses is reported here. For the analysis, central reading at baseline was used for comparison with Week 52 reading. It is graded on a scale of 0-100%; a higher score is worse and indicates greater volume occupied by disease. A negative change from baseline indicated improvement. Baseline was defined as the last available value before the first dose of study drug.
| percent | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Three-dimensional CT Total Volume Occupied by Disease in All Sinuses | -5.73 ± 3.91 | -42.04 ± 3.47 |
SCS use was defined as the use of SCS for rescue treatment of AFRS or for another reason and was captured by the Investigator (or designee) in electronic case report form (eCRF). Participants who underwent or planned to undergo surgery for AFRS were also recorded in eCRF.
| percentage of particpants | Placebo | Dupilumab |
|---|---|---|
| Percentage of Participants Who Received Systemic Corticosteroids (SCS) and/or Underwent or Planned to Undergo Surgery for Allergic Fungal Rhinosinusitis (AFRS) at Week 52 | 31.0 | 3.0 |
The SNOT-22 is a validated questionnaire designed to assess the impact of CRS on participants 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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 24 in SNOT-22 Total Score | -11.63 ± 4.02 | -26.74 ± 3.81 |
Blood samples were collected at specified timepoints for the assessment of IgE. Total IgE was measured with a quantitative method approved for diagnostic testing; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
| percent change | Placebo | Dupilumab |
|---|---|---|
| Percent Change From Baseline in Serum Total Immunoglobulin-E (IgE) to Week 52 | 6.91 ± 10.86 | -73.81 ± 11.40 |
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. Severity of rhinorrhea (average of anterior \[runny nose\]/posterior nasal discharge \[post-nasal drip\]) is presented here. Baseline was defined as the average of the scores in the 7 days prior to the first dose of study drug.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Week 24 | -0.44 ± 0.13 | -0.92 ± 0.12 |
| Week 52 | -0.33 ± 0.15 | -1.09 ± 0.13 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Monthly Average TSS Derived From the Nasal Symptom Diary | -0.71 ± 0.39 | -4.10 ± 0.35 |
The rhinosinusitis VAS is used to evaluate the overall severity of the rhinosinusitis. It is a recommended scale to determine the participant's disease severity and to guide the treatment for CRS. The participant is asked to answer the following question: "How troublesome are your symptoms of your rhinosinusitis" on a 10-centimeter VAS from 0 = not troublesome to 10 = worst thinkable troublesome. Based on their score on the VAS, the severity of rhinosinusitis is divided into 3 categories as follows: mild = VAS 0 to 3, moderate = VAS \>3 to 7 and severe = VAS \>7 to 10; 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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Week 24 | -1.29 ± 0.61 | -4.30 ± 0.58 |
| Week 52 | -1.20 ± 0.57 | -5.52 ± 0.54 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in UPSIT | 2.12 ± 1.73 | 9.45 ± 1.57 |
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.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Change From Baseline to Week 52 in Monthly Average Decreased/Loss of Smell Using the Nasal Symptom Diary | -0.24 ± 0.17 | -1.41 ± 0.16 |
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.
| Participants | Placebo | Dupilumab |
|---|---|---|
| TEAEs | 22 | 23 |
| TESAEs | 3 | 0 |
Blood samples were collected at the specified timepoints to obtain serum concentration of dupilumab.
| nanogram/milliliter | Dupilumab |
|---|---|
| Day 1 | 0.00 ± 0.00 |
| Week 12 | 47750.00 ± 17828.70 |
| Week 24 | 49597.78 ± 26542.80 |
| Week 52 | 57284.21 ± 27401.32 |
Blood samples were collected at specified timepoints for the assessment of fungal-specific IgE which was measured with a quantitative method approved for diagnostic testing; a negative change from baseline indicated improvement. Baseline was defined as the last available value before the first dose of study drug.
| percent change | Placebo | Dupilumab |
|---|---|---|
| A. fumigatus Antigen IgE Antibody (AB) | -65.79 | -77.20 ± 9.00 |
| F. proliferatum Antigen IgE AB | -20.18 ± 38.03 | -66.09 ± 16.88 |
| C. lunata Antigen IgE AB | 1.56 ± 29.80 | -74.82 ± 12.34 |
| S. rostrata Antigen IgE AB | 28.89 ± 52.58 | -61.77 ± 14.37 |
| C. albicans Antigen IgE AB | 15.69 ± 33.17 | -63.60 ± 17.06 |
| B. spicifera Antigen IgE AB | 19.12 ± 52.10 | -56.26 ± 22.36 |
| A. niger Antigen IgE AB | 2.46 ± 55.43 | -67.48 ± 13.72 |
| A. flavus Antigen IgE AB | 0.75 ± 44.77 | -52.94 ± 19.62 |
| A. tenuis alternata Antigen IgE AB | 16.06 ± 47.96 | -56.07 ± 21.78 |
| Mould Mix 2 IgE | -17.50 ± 29.93 | -66.81 ± 20.86 |
Plasma samples were collected to evaluate antibodies to dupilumab. Treatment-emergent ADA responses were defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing.
| Participants | Placebo | Dupilumab |
|---|---|---|
| Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to Dupilumab | 0 | 1 |
Collected over Adverse events and deaths were assessed from first dose of study drug (Day 1) up to end of follow-up per participant, up to approximately 64 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/28 (0%) | 3/28 (10.7%) | 15/28 (53.6%) |
| Dupilumab | 0/33 (0%) | 0/33 (0%) | 16/33 (48.5%) |
| Event | Placebo | Dupilumab |
|---|---|---|
| Allergic Fungal RhinosinusitisRespiratory, thoracic and mediastinal disorders | 2/28 | 0/33 |
| InfectionInfections and infestations | 1/28 | 0/33 |
| UreterolithiasisRenal and urinary disorders | 1/28 | 0/33 |
| Event | Placebo | Dupilumab |
|---|---|---|
| Allergic Fungal RhinosinusitisRespiratory, thoracic and mediastinal disorders | 6/28 | 1/33 |
| Covid-19Infections and infestations | 4/28 | 5/33 |
| Accidental OverdoseInjury, poisoning and procedural complications | 4/28 | 3/33 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/28 | 4/33 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/28 | 0/33 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 2/28 | 0/33 |
| Thermal BurnInjury, poisoning and procedural complications | 2/28 | 0/33 |
| Suspected Covid-19Infections and infestations | 0/28 | 2/33 |
| HeadacheNervous system disorders | 0/28 | 2/33 |
| Abdominal PainGastrointestinal disorders | 0/28 | 2/33 |
Analysis was performed on randomized population which included all participants from screened population who were allocated to a randomized drug by interactive response technology regardless of whether the drug was received or not.
| Age, Continuous(years) | Placebo | Dupilumab | Total |
|---|---|---|---|
| Mean | 37.4 ± 14.0 | 41.9 ± 17.5 | 39.8 ± 16.0 |
| Sex: Female, Male(Participants) | Placebo | Dupilumab | Total |
|---|---|---|---|
| Female | 4 | 13 | 17 |
| Male | 25 | 20 | 45 |
| Race (NIH/OMB)(Participants) | Placebo | Dupilumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 13 | 12 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 12 | 15 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Lund Mackay (LMK) score(score on a scale) | Placebo | Dupilumab | Total |
|---|---|---|---|
| Mean | 18.4 ± 3.4 | 17.5 ± 3.8 | 17.9 ± 3.6 |
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Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Allergic Fungal Sinusitis
Sanofi