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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 276 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02912468
The ClinicalTrials.gov registry entry for NCT02912468 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 276 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.
NCT02912468 reports 0 study locations.
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.
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