Trial · NCT01920893

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

NCT01920893, Phase 2, Completed, Sanofi; results first posted 2017-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis. Trials, record NCT01920893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01920893

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Trial

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

Title: An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
NCT number: NCT01920893
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Sanofi
Conditions: Nasal Polyps
Interventions: Placebo (for dupilumab), Dupilumab, Mometasone furoate nasal spray
First posted: 2013-08-12
Last updated: 2017-06-26
Other registries' IDs: eudract:2013-001803-35
Results first posted: 2017-06-02
Limitations and caveats: Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Baseline, Week 16	NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.
Secondary	Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma	Baseline, Week 16	NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.
Secondary	Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16	Baseline, Week 16	Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea \[runny nose\], posterior rhinorrhea \[post nasal drip\], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.
Secondary	Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16	Baseline, Week 16	Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.
Secondary	Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16	Baseline, Week 16	NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.
Secondary	Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16	Baseline, Week 16	UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.
Secondary	Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score	Baseline, Week 16	CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.
Secondary	Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease	Baseline, Week 16	CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.
Secondary	Time to First Response in NPS: Kaplan-Meier Estimate at Week 16	Baseline to Week 16	The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as \>=1 point reduction from baseline score); for participants without NPS \>=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.
Secondary	Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16	Baseline, Week 16	The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.

Source ClinicalTrials.gov

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Baseline, Week 16	Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points.	score on a scale	MEAN
SECONDARY	Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma	Baseline, Week 16	Participants of the ITT population with asthma and with available data at Week 16.	score on a scale	MEAN
SECONDARY	Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16	Baseline, Week 16	Participants from ITT population with data available for symptom score at Week 16.	score on a scale	MEAN
SECONDARY	Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16	Baseline, Week 16	Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16.	centimetre (cm)	MEAN
SECONDARY	Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16	Baseline, Week 16	Participants from ITT population with data available for NPIF at Week 16.	liter/minute	MEAN
SECONDARY	Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16	Baseline, Week 16	Participants from ITT population with data available for UPSIT at Week 16.	score on scale	MEAN
SECONDARY	Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score	Baseline, Week 16	Participants from ITT population with CT scan data available at Week 16.	score on scale	MEAN
SECONDARY	Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease	Baseline, Week 16	Participants from ITT population with CT scan data available at Week 16.	percent area	MEAN
SECONDARY	Time to First Response in NPS: Kaplan-Meier Estimate at Week 16	Baseline to Week 16	ITT population.	Probability of response	NUMBER
SECONDARY	Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16	Baseline, Week 16	Participants from ITT population with SNOT-22 data available at Week 16.	score on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group36

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Placebo	Baseline	5.67	Standard Deviation 0.88	score on a scale
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Dupilumab 300 mg QW	Baseline	5.87	Standard Deviation 1.01	score on a scale
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Placebo	Week 16	5.39	Standard Deviation 1.47	score on a scale
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Dupilumab 300 mg QW	Week 16	3.97	Standard Deviation 1.9	score on a scale
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Placebo	Change from baseline at Week 16	-0.26	Standard Deviation 1.32	score on a scale
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16	Dupilumab 300 mg QW	Change from baseline at Week 16	-1.9	Standard Deviation 1.76	score on a scale
Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma	Placebo		0.27	Standard Deviation 0.88	score on a scale
Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma	Dupilumab 300 mg QW		-2.4	Standard Deviation 2.03	score on a scale
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16	Placebo	Congestion/obstruction	-0.26	Standard Deviation 0.7	score on a scale
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16	Dupilumab 300 mg QW	Congestion/obstruction	-0.95	Standard Deviation 0.86	score on a scale

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	30
Overall Study	STARTED	Dupilumab 300 mg QW	30
Overall Study	Treated (Safety Population)	Placebo	30
Overall Study	Treated (Safety Population)	Dupilumab 300 mg QW	30
Overall Study	COMPLETED	Placebo	23
Overall Study	COMPLETED	Dupilumab 300 mg QW	28
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Dupilumab 300 mg QW	2

Source ClinicalTrials.gov

Adverse events60

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
other	Bronchitis	Infections and infestations	Placebo	4	30
other	Bronchitis	Infections and infestations	Dupilumab 300 mg QW	1	30
other	Nasopharyngitis	Infections and infestations	Placebo	10	30
other	Nasopharyngitis	Infections and infestations	Dupilumab 300 mg QW	14	30
other	Sinusitis	Infections and infestations	Placebo	1	30
other	Sinusitis	Infections and infestations	Dupilumab 300 mg QW	2	30
other	Upper respiratory tract infection	Infections and infestations	Placebo	0	30
other	Upper respiratory tract infection	Infections and infestations	Dupilumab 300 mg QW	4	30
other	Dizziness	Nervous system disorders	Placebo	1	30
other	Dizziness	Nervous system disorders	Dupilumab 300 mg QW	3	30

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	30
Total, all-cause mortality	Dupilumab 300 mg QW	0	30
Total, other adverse events	Placebo	22	30
Total, other adverse events	Dupilumab 300 mg QW	27	30
Total, serious adverse events	Placebo	4	30
Total, serious adverse events	Dupilumab 300 mg QW	2	30

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26836729	RESULT	PubMed
30488542	DERIVED	PubMed
30954643	DERIVED	PubMed
31306495	DERIVED	PubMed
32075470	DERIVED	PubMed
33710614	DERIVED	PubMed
34437720	DERIVED	PubMed
34848949	DERIVED	PubMed

Grants0

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

None in this release.

Trial comparisons2

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

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

Tests0

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

None in this release.

Data dates

The day each source was copied for this release.

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

Sources 3

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

Each source's terms

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

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

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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