Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 448 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02898454
The ClinicalTrials.gov registry entry for NCT02898454 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 448 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02898454 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.