Trial · NCT02912468

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

NCT02912468, Phase 3, Completed, Sanofi; results first posted 2019-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps. Trials, record NCT02912468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02912468

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Trial

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

Title: A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
NCT number: NCT02912468
Status: Completed
Phases: Phase 3
Enrollment: 276 participants, actual
Lead sponsor: Sanofi
Conditions: Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Interventions: Dupilumab SAR231893 (REGN668), Placebo, Mometasone furoate 50 micrograms
First posted: 2016-09-23
Last updated: 2019-07-25
Other registries' IDs: eudract:2015-003101-42
Results first posted: 2019-07-25

Source ClinicalTrials.gov

Registered outcomes37

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

List	Outcome	Time frame	Description
Primary	Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score	Baseline, Week 24	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.
Primary	Change From Baseline at Week 24 in Nasal Polyp Score	Baseline, Week 24	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.
Secondary	Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score	Baseline, Week 24	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.
Secondary	Change From Baseline at Week 24 in Total Symptom Score (TSS)	Baseline, Week 24	The TSS was the sum of participant-assessed nasal symptom scores for nasal congestion/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.
Secondary	Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score	Baseline, Week 24	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.
Secondary	Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily	Baseline, Week 24	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.
Secondary	Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores	Baseline, Week 24	The SNOT-22 is a validated questionnaire that 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.
Secondary	Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method	Baseline up to Week 24	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, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone. * 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 24 was obtained using Kaplan-Meier method.
Secondary	Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis	Baseline, Week 24	The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) 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 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.
Secondary	Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)	Baseline, Week 24	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 are indicative of better nasal air flow. 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.

1 to 10 of 37Source ClinicalTrials.gov

See all 37 registered outcomes

Outcomes37

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score	Baseline, Week 24	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.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline at Week 24 in Nasal Polyp Score	Baseline, Week 24	The analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score	Baseline, Week 24	The analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in Total Symptom Score (TSS)	Baseline, Week 24	The analysis was performed on ITT population.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score	Baseline, Week 24	The analysis was performed on ITT. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily	Baseline, Week 24	The analysis was performed on ITT population.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores	Baseline, Week 24	The analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method	Baseline up to Week 24	The analysis was performed on ITT population.	percentage of participants with event	NUMBER
SECONDARY	Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis	Baseline, Week 24	The analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)	Baseline, Week 24	The analysis was performed on ITT population.	liters per minute	LEAST_SQUARES_MEAN

1 to 10 of 37Source ClinicalTrials.gov

See all 37 outcomes

Results by group135

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

Outcome	Group	Value	Spread	Units
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score	Placebo	-0.45	Standard Error 0.07	score on a scale
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score	Dupilumab 300 mg	-1.34	Standard Error 0.07	score on a scale
Change From Baseline at Week 24 in Nasal Polyp Score	Placebo	0.17	Standard Error 0.15	score on a scale
Change From Baseline at Week 24 in Nasal Polyp Score	Dupilumab 300 mg	-1.89	Standard Error 0.14	score on a scale
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score	Placebo	-0.74	Standard Error 0.37	score on a scale
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score	Dupilumab 300 mg	-8.18	Standard Error 0.34	score on a scale
Change From Baseline at Week 24 in Total Symptom Score (TSS)	Placebo	-1.17	Standard Error 0.17	score on a scale
Change From Baseline at Week 24 in Total Symptom Score (TSS)	Dupilumab 300 mg	-3.77	Standard Error 0.16	score on a scale
Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score	Placebo	0.70	Standard Error 0.71	score on a scale
Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score	Dupilumab 300 mg	11.26	Standard Error 0.67	score on a scale

1 to 10 of 135Source ClinicalTrials.gov

See all 135 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	133
Overall Study	STARTED	Dupilumab 300 mg	143
Overall Study	Treated	Placebo	133
Overall Study	Treated	Dupilumab 300 mg	142
Overall Study	Safety Population	Placebo	132
Overall Study	Safety Population	Dupilumab 300 mg	143
Overall Study	COMPLETED	Placebo	124
Overall Study	COMPLETED	Dupilumab 300 mg	138
Overall Study	NOT COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Dupilumab 300 mg	5

Source ClinicalTrials.gov

Adverse events48

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection Site Erythema	General disorders	Placebo	12	132	30
other	Injection Site Erythema	General disorders	Dupilumab 300 mg	8	143	25
other	Bronchitis	Infections and infestations	Placebo	8	132	8
other	Bronchitis	Infections and infestations	Dupilumab 300 mg	0	143	0
other	Nasopharyngitis	Infections and infestations	Placebo	20	132	25
other	Nasopharyngitis	Infections and infestations	Dupilumab 300 mg	19	143	25
other	Headache	Nervous system disorders	Placebo	11	132	13
other	Headache	Nervous system disorders	Dupilumab 300 mg	7	143	7
other	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo	8	132	11
other	Asthma	Respiratory, thoracic and mediastinal disorders	Dupilumab 300 mg	3	143	3

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	132
Total, all-cause mortality	Dupilumab 300 mg	0	143
Total, other adverse events	Placebo	61	132
Total, other adverse events	Dupilumab 300 mg	55	143
Total, serious adverse events	Placebo	19	132
Total, serious adverse events	Dupilumab 300 mg	6	143

Source ClinicalTrials.gov

Papers20

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31543428	DERIVED	PubMed
33465455	DERIVED	PubMed
33548517	DERIVED	PubMed
33611847	DERIVED	PubMed
33710614	DERIVED	PubMed
34437720	DERIVED	PubMed
34459002	DERIVED	PubMed
34817082	DERIVED	PubMed
34850966	DERIVED	PubMed
34911163	DERIVED	PubMed

1 to 10 of 20

See all 20 papers

Grants0

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

None in this release.

Trial comparisons2

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

Comparison	Source
Dupilumab 300 mg vs Placebo: deaths from any cause	Trial comparisons
Dupilumab 300 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

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

None in this release.

Data dates

The day each source was copied for this release.

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

Sources 3

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

Each source's terms

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

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

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