A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
Public ClinicalTrials.gov record NCT02912468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective. Secondary Objectives: * To evaluate the efficacy of dupilumab in improving total symptoms score (TSS). * To evaluate the efficacy of dupilumab in improving sense of smell. * To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan). * To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery. * To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22). * To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]). * To evaluate residual effect in follow up. * To evaluate the safety of dupilumab in participants with bilateral NP. * To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.
Study identification
- NCT ID
- NCT02912468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 276 participants
Conditions and interventions
Interventions
- Dupilumab SAR231893 (REGN668) Drug
- Placebo Drug
- Mometasone furoate 50 micrograms Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 5, 2016 (Actual)
- Primary completion
- Jul 5, 2018 (Actual)
- Completion
- Jul 5, 2018 (Actual)
- Last update posted
- Jul 25, 2019
2016 – 2018
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400009 | Long Beach | California | 90720 | — |
| Investigational Site Number 8400004 | Orange | California | 92868 | — |
| Investigational Site Number 8400014 | San Diego | California | 92123 | — |
| Investigational Site Number 8400002 | Stockton | California | 95207 | — |
| Investigational Site Number 8400016 | Centennial | Colorado | 80112 | — |
| Investigational Site Number 8400013 | Tampa | Florida | 33613 | — |
| Investigational Site Number 8400022 | West Des Moines | Iowa | 50265 | — |
| Investigational Site Number 8400007 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 8400005 | Rochester | Minnesota | 55905 | — |
| Investigational Site Number 8400021 | St Louis | Missouri | 63141 | — |
| Investigational Site Number 8400008 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 8400019 | Tulsa | Oklahoma | 74136 | — |
| Investigational Site Number 8400020 | Medford | Oregon | 97504 | — |
| Investigational Site Number 8400018 | Charleston | South Carolina | 29425 | — |
| Investigational Site Number 8400003 | Nashville | Tennessee | 37232-8695 | — |
| Investigational Site Number 8400001 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8400015 | Norfolk | Virginia | 23507 | — |
| Investigational Site Number 8400010 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02912468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02912468 live on ClinicalTrials.gov.