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NCT02898454 · ClinicalTrials.gov registry record · Phase 3
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
NCT02898454: Completed Phase 3 study, sponsored by Sanofi.
NCT02898454 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 448 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02898454, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: * To evaluate the efficacy of dupilumab in improving total symptoms score. * 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 Japanese participants). * To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. * To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. * To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. * 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. All participants randomized to receive Dupilumab had been on 300 mg q2
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893 (REGN668)
- DRUG Mometasone furoate nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2016-11-28 |
| Est. Completion | 2018-11-16 |
| Phase | Phase 3 |
What the finished NCT02898454 record still lists
NCT02898454 is an interventional study that assigns participants to a tested intervention. The registered 448 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 (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02898454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02898454 about?
NCT02898454 is a clinical study titled "Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps". Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps ...
What is the current status of trial NCT02898454?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2016-11-28. Estimated completion is 2018-11-16.
What interventions are being tested in trial NCT02898454?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (REGN668) (DRUG), Mometasone furoate nasal spray (DRUG).
Who is sponsoring clinical trial NCT02898454?
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 NCT02898454's enrollment target sits among peer trials
448 864th of 2000 higher than 1,137 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
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