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Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps (SINUS-52)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898454
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Interventions Drug: Dupilumab SAR231893 (REGN668)
Drug: Placebo
Drug: Mometasone furoate nasal spray
Enrollment 448
Recruitment Details Study participants were involved in the study from 28 November 2016 to 16 November 2018 at 117 centers in 14 countries. A total of 806 participants were screened, of which 448 participants were enrolled and randomized to receive dupilumab 300 mg or placebo. A total of 358 participants had screen failures due to failure to meet inclusion criteria.
Pre-assignment Details Randomization was stratified according to asthma and/or non-steroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD) history (yes/no), prior nasal polyps (NP) surgery (yes or not), and country.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description Placebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg every 4 weeks (q4w) until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Period Title: Overall Study
Started [1] 153 145 150
Intent-to-Treat (ITT) Population [2] 153 145 150
Treated 152 145 150
Safety Population 150 [3] 148 [4] 149
Completed 136 140 144
Not Completed 17 5 6
Reason Not Completed
Adverse Event             4             1             2
Protocol Violation             1             0             1
Lack of Efficacy             4             1             0
Withdrawal by Subject             6             3             3
Lost to Follow-up             1             0             0
Did Not Met Eligibility Criteria             1             0             0
[1]
Randomized population
[2]
Randomized participants who were analyzed according to treatment group allocated by randomization.
[3]
2 participants randomized to placebo received 1 dose of dupilumab:counted in 300 mg q2w then q4w arm
[4]
1 randomized to dupilumab q2w arm received 1dose of placebo: counted in 300 mg q2w then q4w arm.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300mg q2w Total
Hide Arm/Group Description Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose. Total of all reporting groups
Overall Number of Baseline Participants 153 145 150 448
Hide Baseline Analysis Population Description
Analysis was performed on randomized population which included any participant who was allocated to a randomized treatment regardless of whether any treatment kit was used.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 145 participants 150 participants 448 participants
51.67  (12.66) 52.28  (12.87) 51.91  (11.88) 51.95  (12.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 145 participants 150 participants 448 participants
Female
58
  37.9%
58
  40.0%
53
  35.3%
169
  37.7%
Male
95
  62.1%
87
  60.0%
97
  64.7%
279
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 145 participants 150 participants 448 participants
Hispanic or Latino
40
  26.1%
42
  29.0%
50
  33.3%
132
  29.5%
Not Hispanic or Latino
113
  73.9%
102
  70.3%
100
  66.7%
315
  70.3%
Unknown or Not Reported
0
   0.0%
1
   0.7%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 145 participants 150 participants 448 participants
Caucasian/White
128
  83.7%
120
  82.8%
124
  82.7%
372
  83.0%
Black/of African descent
3
   2.0%
2
   1.4%
2
   1.3%
7
   1.6%
Asian/Oriental
18
  11.8%
19
  13.1%
17
  11.3%
54
  12.1%
American Indian or Alaska Native
3
   2.0%
2
   1.4%
7
   4.7%
12
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.7%
0
   0.0%
1
   0.2%
Multiple
1
   0.7%
1
   0.7%
0
   0.0%
2
   0.4%
Nasal Congestion/Obstruction (NC) Symptom Severity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 153 participants 145 participants 150 participants 448 participants
2.38  (0.54) 2.44  (0.59) 2.48  (0.62) 2.43  (0.59)
[1]
Measure Description: NC symptom severity was assessed by the participants on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity.
Nasal Polyp Score (NPS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 152 participants 145 participants 149 participants 446 participants
5.96  (1.21) 6.29  (1.20) 6.07  (1.22) 6.10  (1.21)
[1]
Measure Description: NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), with higher score representing more severe disease.
[2]
Measure Analysis Population Description: "Number analyzed" = Number of participants evaluable for the specified baseline measure.
1.Primary Outcome
Title Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score
Hide Description NC symptom severity was assessed by the participants on a daily basis from visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on intent-to-treat (ITT) population which included all randomized participants who were analyzed according to the treatment group allocated by randomization. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 153 295
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.38  (0.07) -1.25  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.03 to -0.71
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline at Week 24 in Nasal Polyp Score
Hide Description NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Total NPS: sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 152 294
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.10  (0.14) -1.71  (0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-2.10 to -1.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 150 289
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.09  (0.31) -5.21  (0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.13
Confidence Interval (2-Sided) 95%
-5.80 to -4.46
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline at Week 24 in Total Symptom Score (TSS)
Hide Description The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 153 295
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.00  (0.20) -3.45  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.44
Confidence Interval (2-Sided) 95%
-2.87 to -2.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score
Hide Description The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 150 287
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.81  (0.71) 9.71  (0.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 10.52
Confidence Interval (2-Sided) 95%
8.98 to 12.07
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily
Hide Description The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 153 295
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.23  (0.08) -1.21  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-1.15 to -0.81
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
Hide Description The SNOT-22 is a validated questionnaire was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 152 292
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-10.40  (1.61) -27.77  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg (24 Weeks Pooled Arm)
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.36
Confidence Interval (2-Sided) 95%
-20.87 to -13.85
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Polyp Score
Hide Description NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, "overall number of participants analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 152 145 149
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.16  (0.15) -2.05  (0.15) -2.24  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w Then q4w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.21
Confidence Interval (2-Sided) 95%
-2.59 to -1.83
Estimation Comments Dupilumab 300 mg q2w then q4w vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.41
Confidence Interval (2-Sided) 95%
-2.78 to -2.03
Estimation Comments Dupilumab 300 mg q2w vs. Placebo
9.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score
Hide Description NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 153 145 150
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.37  (0.08) -1.48  (0.08) -1.36  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w Then q4w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-1.30 to -0.92
Estimation Comments Dupilumab 300 mg q2w then q4w vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-1.18 to -0.80
Estimation Comments Dupilumab 300 mg q2w vs. Placebo
10.Secondary Outcome
Title Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores
Hide Description The SNOT-22 is a validated questionnaire that was used to assess the impact of CRSwNP on HRQoL. It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 152 145 147
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-9.06  (1.61) -30.42  (1.65) -29.79  (1.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w Then q4w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -21.36
Confidence Interval (2-Sided) 95%
-25.45 to -17.27
Estimation Comments Dupilumab 300 mg q2w then q4w vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.
Type of Statistical Test Superiority
Comments Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -20.73
Confidence Interval (2-Sided) 95%
-24.81 to -16.65
Estimation Comments Dupilumab 300 mg q2w vs. Placebo
11.Secondary Outcome
Title Rescue Treatment Use: Estimate of Percentage of Participants With Greater Than or Equal to (>=) 1 Event by Week 52 Obtained Using Kaplan-Meier Method
Hide Description

Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:

  • SCS: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide.
  • Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.

Estimate of percentage of participants with event by Week 52 was obtained using Kaplan-Meier method.

Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Data for this outcome measure was planned to be collected and analyzed for the pooled population of participants receiving Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants who either received Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 or Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52, added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 153 295
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with event
SCS treatment
42.5
(34.5 to 50.2)
13.1
(9.0 to 18.0)
NP surgery
28.3
(21.2 to 35.7)
5.5
(2.9 to 9.4)
12.Secondary Outcome
Title Change From Baseline at Week 52 in Total Symptom Score
Hide Description The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 153 145 150
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.93  (0.20) -4.17  (0.20) -3.79  (0.20)
13.Secondary Outcome
Title Change From Baseline at Week 52 in the University of Pennsylvania Smell Identification Test Score
Hide Description The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 150 142 145
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.78  (0.71) 9.99  (0.73) 9.53  (0.72)
14.Secondary Outcome
Title Change From Baseline at Week 52 in Severity of Decreased/Loss of Smell
Hide Description The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 153 145 150
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.18  (0.09) -1.49  (0.09) -1.29  (0.08)
15.Secondary Outcome
Title Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund-Mackay Score
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 150 140 149
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.11  (0.37) -5.60  (0.37) -6.83  (0.37)
16.Secondary Outcome
Title Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis
Hide Description The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 150 289
Least Squares Mean (Standard Error)
Unit of Measure: centimeters
-1.39  (0.24) -4.32  (0.19)
17.Secondary Outcome
Title Change From Baseline at Week 52 in Visual Analogue Scale for Rhinosinusitis
Hide Description The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 150 143 146
Least Squares Mean (Standard Error)
Unit of Measure: centimeters
-0.93  (0.26) -4.39  (0.26) -4.74  (0.26)
18.Secondary Outcome
Title Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)
Hide Description NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values were indicative of better nasal air flow. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 153 295
Least Squares Mean (Standard Error)
Unit of Measure: liters per minute
18.65  (3.95) 55.29  (3.08)
19.Secondary Outcome
Title Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score
Hide Description Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 153 295
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.40  (0.07) -0.99  (0.05)
20.Secondary Outcome
Title Change From Baseline at Week 52 in Rhinorrhea Daily Symptom Score
Hide Description Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 153 145 150
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.35  (0.07) -1.19  (0.07) -1.15  (0.07)
21.Secondary Outcome
Title Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period
Hide Description SCS included: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide. For every participant, the total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 64 participants (placebo group), 17 participants (dupilumab 300 mg q2w then q4w) and 22 participants (dupilumab 300 mg q2w) was derived.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT population. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 64 17 22
Mean (Standard Deviation)
Unit of Measure: milligrams
547.56  (665.40) 282.38  (243.15) 389.68  (502.61)
22.Secondary Outcome
Title Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant
Hide Description Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS Rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 64 17 22
Mean (Standard Deviation)
Unit of Measure: days
19.58  (17.67) 10.71  (9.00) 23.23  (55.23)
23.Secondary Outcome
Title Changed From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 90 176
Least Squares Mean (Standard Error)
Unit of Measure: liters
-0.05  (0.05) 0.17  (0.04)
24.Secondary Outcome
Title Change From Baseline at Week 52 in Forced Expiratory Volume in 1 Second for Participants With Asthma
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 90 91 85
Least Squares Mean (Standard Error)
Unit of Measure: liters
-0.18  (0.05) 0.10  (0.05) 0.06  (0.05)
25.Secondary Outcome
Title Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) for Participants With Asthma
Hide Description ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 90 171
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.08  (0.09) -0.78  (0.07)
26.Secondary Outcome
Title Change From Baseline at Week 52 in Asthma Control Questionnaire-6 for Participants With Asthma
Hide Description ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with Asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 90 89 82
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.12  (0.10) -0.76  (0.10) -0.83  (0.10)
27.Secondary Outcome
Title Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma
Hide Description NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 91 176
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.39  (0.09) -1.36  (0.07)
28.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma
Hide Description NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 91 91 85
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.34  (0.09) -1.51  (0.09) -1.44  (0.09)
29.Secondary Outcome
Title Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 88 173
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.27  (0.10) -1.30  (0.08)
30.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 88 85 88
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.25  (0.10) -1.54  (0.10) -1.35  (0.09)
31.Secondary Outcome
Title Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma
Hide Description NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 90 176
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.13  (0.17) -1.88  (0.13)
32.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Asthma
Hide Description NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 90 91 85
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.29  (0.20) -2.25  (0.20) -2.34  (0.20)
33.Secondary Outcome
Title Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 88 172
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.22  (0.19) -1.73  (0.15)
34.Secondary Outcome
Title Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 88 85 87
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.21  (0.21) -2.22  (0.22) -2.56  (0.21)
35.Secondary Outcome
Title Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 89 174
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.33  (0.40) -5.86  (0.31)
36.Secondary Outcome
Title Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 89 89 85
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.20  (0.46) -6.23  (0.45) -7.22  (0.47)
37.Secondary Outcome
Title Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 85 169
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.10  (0.42) -5.42  (0.33)
38.Secondary Outcome
Title Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery
Hide Description The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 85 82 87
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.06  (0.50) -6.01  (0.50) -7.45  (0.49)
39.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
Hide Description An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of drug until 84 days following the last administration of drug. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Time Frame Baseline up to 84 days after last dose of study drug (up to 64 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the investigational medicinal product (IMP), analyzed according to the treatment actually received.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 150 148 149
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
138
  92.0%
134
  90.5%
125
  83.9%
Any treatment emergent SAE
16
  10.7%
12
   8.1%
8
   5.4%
Any TEAE leading to death
0
   0.0%
1
   0.7%
0
   0.0%
TEAE leading to treatment discontinuation
17
  11.3%
2
   1.4%
6
   4.0%
40.Secondary Outcome
Title Change From Baseline at Week 24 in European Quality of Life 5 Dimension Scale (EQ-5D) Visual Analog Scale Score
Hide Description The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.
Arm/Group Title Placebo Dupilumab 300 mg (24 Weeks Pooled Arm)
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
Overall Number of Participants Analyzed 151 289
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
3.91  (1.50) 10.83  (1.16)
41.Secondary Outcome
Title Change From Baseline at Week 52 in European Quality of Life 5 Dimension Scale Visual Analog Scale Score
Hide Description The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 151 143 146
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1.38  (1.60) 11.98  (1.63) 13.14  (1.62)
42.Secondary Outcome
Title Functional Dupilumab Concentration in Serum
Hide Description [Not Specified]
Time Frame Baseline, Week 2, Week 4, Week 16, Week 24, Week 40, End of treatment (Week 52), End of study (Week 64)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on pharmacokinetics population (PK) which included all participants who received at least 1 dose of IMP with at least 1 evaluable functional dupilumab concentration result. Here, 'number analyzed' = number of participants with available data for each time point. PK data was not collected and assessed for the placebo arm.
Arm/Group Title Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description:
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. One participant randomized to dupilumab 300 mg q2w arm received 1 dose of placebo and was counted in the 300 mg q2w then q4w arm.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 146 149
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter
Baseline Number Analyzed 145 participants 146 participants
0.00  (0.00) 0.00  (0.00)
Week 2 Number Analyzed 143 participants 146 participants
21545.79  (9120.36) 22285.67  (8459.01)
Week 4 Number Analyzed 144 participants 144 participants
33760.62  (16419.72) 37326.31  (14226.12)
Week 16 Number Analyzed 143 participants 141 participants
70503.07  (31234.86) 74382.04  (33118.68)
Week 24 Number Analyzed 144 participants 143 participants
75929.41  (35466.00) 79890.06  (35361.97)
Week 40 Number Analyzed 141 participants 138 participants
21052.06  (18588.68) 80526.37  (34048.41)
Week 52 Number Analyzed 141 participants 135 participants
17276.13  (16353.20) 75872.58  (34127.85)
Week 64 Number Analyzed 139 participants 135 participants
53.60  (160.53) 851.30  (2682.21)
43.Secondary Outcome
Title Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies Response (ADA)
Hide Description ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.
Time Frame Baseline to Week 52
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Hide Analysis Population Description
The analysis was performed on ADA population which included participants who received at least 1 dose of IMP with at least one evaluable ADA serum sample that was assayed successfully in the ADA assay (either 'ADA negative' or 'ADA positive') following the first dose of the study medication.
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
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Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. Two participants randomized to placebo arm accidently received 1 dose of dupilumab 300 mg and counted in the 300 mg q2w then q4w arm. One participant randomized to the dupilumab 300 mg q2w arm received 1 dose of placebo and was counted in the 300 mg q2w then q4w arm.
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Overall Number of Participants Analyzed 149 148 148
Measure Type: Count of Participants
Unit of Measure: Participants
With treatment-emergent ADA 6 18 8
With treatment-boosted ADA 1 0 0
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to 64 weeks regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (defined as the period from the time of first dose of drug until 84 days following the last administration of drug). Analysis was performed on safety population.
 
Arm/Group Title Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Hide Arm/Group Description Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
All-Cause Mortality
Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)      1/148 (0.68%)      0/149 (0.00%)    
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Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/150 (10.67%)      12/148 (8.11%)      8/149 (5.37%)    
Blood and lymphatic system disorders       
Eosinophilia  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Ear and labyrinth disorders       
Deafness Neurosensory  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Vestibular Disorder  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Eye disorders       
Retinal Vein Thrombosis  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Gastrointestinal disorders       
Abdominal Pain  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Abdominal Pain Upper  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Gastrointestinal Angiectasia  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Oesophageal Perforation  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Pancreatitis  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
General disorders       
Pyrexia  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Immune system disorders       
Eosinophilic Granulomatosis With Polyangiitis  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Infections and infestations       
Appendicitis  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Chronic Sinusitis  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Corneal Abscess  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Diverticulitis  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Infectious Pleural Effusion  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Pneumonia  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Septic Shock  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Wound Infection  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Injury, poisoning and procedural complications       
Facial Bones Fracture  1  2/150 (1.33%)  2 0/148 (0.00%)  0 0/149 (0.00%)  0
Fall  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Femur Fracture  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Hand Fracture  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Humerus Fracture  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Open Globe Injury  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Traumatic Intracranial Haemorrhage  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Upper Limb Fracture  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Investigations       
Weight Decreased  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Osteoarthritis  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Nasal Neoplasm Benign  1  0/150 (0.00%)  0 0/148 (0.00%)  0 1/149 (0.67%)  1
Nervous system disorders       
Syncope  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Temporal Lobe Epilepsy  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Renal and urinary disorders       
Acute Kidney Injury  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthmatic Crisis  1  0/150 (0.00%)  0 1/148 (0.68%)  1 0/149 (0.00%)  0
Chronic Rhinosinusitis With Nasal Polyps  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Nasal Polyps  1  3/150 (2.00%)  3 1/148 (0.68%)  1 0/149 (0.00%)  0
Social circumstances       
Miscarriage Of Partner  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
Vascular disorders       
Peripheral Arterial Occlusive Disease  1  1/150 (0.67%)  1 0/148 (0.00%)  0 0/149 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dupilumab 300 mg q2w Then q4w Dupilumab 300 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   111/150 (74.00%)      95/148 (64.19%)      90/149 (60.40%)    
General disorders       
Injection Site Erythema  1  11/150 (7.33%)  28 10/148 (6.76%)  26 11/149 (7.38%)  25
Injection Site Reaction  1  3/150 (2.00%)  4 8/148 (5.41%)  24 5/149 (3.36%)  15
Infections and infestations       
Acute Sinusitis  1  16/150 (10.67%)  18 5/148 (3.38%)  5 5/149 (3.36%)  8
Bronchitis  1  8/150 (5.33%)  13 9/148 (6.08%)  10 9/149 (6.04%)  10
Nasopharyngitis  1  38/150 (25.33%)  48 31/148 (20.95%)  53 33/149 (22.15%)  50
Sinusitis  1  17/150 (11.33%)  29 14/148 (9.46%)  19 9/149 (6.04%)  9
Upper Respiratory Tract Infection  1  20/150 (13.33%)  23 8/148 (5.41%)  9 10/149 (6.71%)  13
Injury, poisoning and procedural complications       
Accidental Overdose  1  11/150 (7.33%)  12 12/148 (8.11%)  13 5/149 (3.36%)  5
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/150 (1.33%)  2 12/148 (8.11%)  12 7/149 (4.70%)  9
Back Pain  1  10/150 (6.67%)  11 5/148 (3.38%)  6 8/149 (5.37%)  11
Nervous system disorders       
Headache  1  18/150 (12.00%)  31 17/148 (11.49%)  32 14/149 (9.40%)  17
Respiratory, thoracic and mediastinal disorders       
Asthma  1  20/150 (13.33%)  31 15/148 (10.14%)  23 8/149 (5.37%)  11
Cough  1  8/150 (5.33%)  11 9/148 (6.08%)  10 9/149 (6.04%)  13
Epistaxis  1  20/150 (13.33%)  22 8/148 (5.41%)  10 13/149 (8.72%)  16
Nasal Polyps  1  26/150 (17.33%)  51 20/148 (13.51%)  20 9/149 (6.04%)  14
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
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Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02898454    
Other Study ID Numbers: EFC14280
2015-001314-10 ( EudraCT Number )
U1111-1170-7180 ( Other Identifier: UTN )
First Submitted: September 8, 2016
First Posted: September 13, 2016
Results First Submitted: August 23, 2019
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019