Trial · NCT02898454
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
NCT02898454, Phase 3, Completed, Sanofi; results first posted 2019-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps. Trials, record NCT02898454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02898454
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
- NCT number
- NCT02898454
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 448 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
- Interventions
- Dupilumab SAR231893 (REGN668), Placebo, Mometasone furoate nasal spray
- First posted
- 2016-09-13
- Last updated
- 2019-10-23
- Other registries' IDs
- eudract:2015-001314-10
- Results first posted
- 2019-10-23
Source ClinicalTrials.gov
Registered outcomes43
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. 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. |
| 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. 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. |
| 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. 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. |
| 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 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. |
| 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. 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. |
| 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. 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. |
| 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 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. |
| Secondary | Change From Baseline at Week 52 in Nasal Polyp Score | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores | Baseline, Week 52 | 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. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
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. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline at Week 24 in Nasal Polyp Score | Baseline, Week 24 | 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. | 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 | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in Nasal Polyp Score | Baseline, Week 52 | 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 52 in Nasal Congestion/Obstruction Symptom Severity Score | Baseline, Week 52 | Analysis was performed on ITT population. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores | Baseline, Week 52 | 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 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score | Placebo | -0.38 | Standard Error 0.07 | score on a scale | |
| Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score | Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.25 | Standard Error 0.06 | score on a scale | |
| Change From Baseline at Week 24 in Nasal Polyp Score | Placebo | 0.10 | Standard Error 0.14 | score on a scale | |
| Change From Baseline at Week 24 in Nasal Polyp Score | Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.71 | Standard Error 0.11 | score on a scale | |
| Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score | Placebo | -0.09 | Standard Error 0.31 | score on a scale | |
| Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score | Dupilumab 300 mg (24 Weeks Pooled Arm) | -5.21 | Standard Error 0.24 | score on a scale | |
| Change From Baseline at Week 24 in Total Symptom Score (TSS) | Placebo | -1.00 | Standard Error 0.20 | score on a scale | |
| Change From Baseline at Week 24 in Total Symptom Score (TSS) | Dupilumab 300 mg (24 Weeks Pooled Arm) | -3.45 | Standard Error 0.15 | score on a scale | |
| Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score | Placebo | -0.81 | 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 (24 Weeks Pooled Arm) | 9.71 | Standard Error 0.56 | score on a scale |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 153 | |
| Overall Study | STARTED | Dupilumab 300 mg q2w Then q4w | 145 | |
| Overall Study | STARTED | Dupilumab 300 mg q2w | 150 | |
| Overall Study | Intent-to-Treat (ITT) Population | Placebo | 153 | |
| Overall Study | Intent-to-Treat (ITT) Population | Dupilumab 300 mg q2w Then q4w | 145 | |
| Overall Study | Intent-to-Treat (ITT) Population | Dupilumab 300 mg q2w | 150 | |
| Overall Study | Treated | Placebo | 152 | |
| Overall Study | Treated | Dupilumab 300 mg q2w Then q4w | 145 | |
| Overall Study | Treated | Dupilumab 300 mg q2w | 150 | |
| Overall Study | Safety Population | Placebo | 150 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events165
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 | 11 | 150 | 28 |
| other | Injection Site Erythema | General disorders | Dupilumab 300 mg q2w Then q4w | 10 | 148 | 26 |
| other | Injection Site Erythema | General disorders | Dupilumab 300 mg q2w | 11 | 149 | 25 |
| other | Injection Site Reaction | General disorders | Placebo | 3 | 150 | 4 |
| other | Injection Site Reaction | General disorders | Dupilumab 300 mg q2w Then q4w | 8 | 148 | 24 |
| other | Injection Site Reaction | General disorders | Dupilumab 300 mg q2w | 5 | 149 | 15 |
| other | Acute Sinusitis | Infections and infestations | Placebo | 16 | 150 | 18 |
| other | Acute Sinusitis | Infections and infestations | Dupilumab 300 mg q2w Then q4w | 5 | 148 | 5 |
| other | Acute Sinusitis | Infections and infestations | Dupilumab 300 mg q2w | 5 | 149 | 8 |
| other | Bronchitis | Infections and infestations | Placebo | 8 | 150 | 13 |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 150 |
| Total, all-cause mortality | Dupilumab 300 mg q2w Then q4w | 1 | 148 |
| Total, all-cause mortality | Dupilumab 300 mg q2w | 0 | 149 |
| Total, other adverse events | Placebo | 111 | 150 |
| Total, other adverse events | Dupilumab 300 mg q2w Then q4w | 95 | 148 |
| Total, other adverse events | Dupilumab 300 mg q2w | 90 | 149 |
| Total, serious adverse events | Placebo | 16 | 150 |
| Total, serious adverse events | Dupilumab 300 mg q2w Then q4w | 12 | 148 |
| Total, serious adverse events | Dupilumab 300 mg q2w | 8 | 149 |
Source ClinicalTrials.gov
Papers28
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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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