Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02912468 · ClinicalTrials.gov registry record · Phase 3
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT02912468: Completed Phase 3 study, sponsored by Sanofi.
NCT02912468 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02912468, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893 (REGN668)
- DRUG Mometasone furoate 50 micrograms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2016-12-05 |
| Est. Completion | 2018-07-05 |
| Phase | Phase 3 |
What the finished NCT02912468 record still lists
NCT02912468 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02912468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02912468 about?
NCT02912468 is a clinical study titled "A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps". 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 n...
What is the current status of trial NCT02912468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2016-12-05. Estimated completion is 2018-07-05.
What interventions are being tested in trial NCT02912468?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (REGN668) (DRUG), Mometasone furoate 50 micrograms (DRUG).
Who is sponsoring clinical trial NCT02912468?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02912468's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01371630 · 276 participants · Phase 1
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
- NCT04192344 · 276 participants · Phase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
- NCT05294991 · 276 participants · NA
Wellness App for Sleep Disturbance in Hematological Cancer Patients
- NCT05610852 · 276 participants · NA
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI