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NCT01920893 · ClinicalTrials.gov registry record · Phase 2

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT01920893 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 60 participants.

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The verdict

NCT01920893, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo. Secondary Objectives: To evaluate effect of dupilumab with regards to: * symptoms of sinusitis, * sinus computed tomography (CT) scan, * NPS in the sub-group of participants with co-morbid asthma, * Safety and tolerability.

Interventions

  • DRUG Dupilumab
  • DRUG Placebo (for dupilumab)
  • DRUG Mometasone furoate nasal spray

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2013-08
Est. Completion 2014-11
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT01920893

The ClinicalTrials.gov registry entry for NCT01920893 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 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 Dupilumab is the first listed.

NCT01920893 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01920893 about?

NCT01920893 is a clinical study titled "An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis". Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo. Secondary Objectives: To evaluate effect of dupilumab with regards to: * symptoms of s...

What is the current status of trial NCT01920893?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-08. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01920893?

The interventions under investigation include: Dupilumab (DRUG), Placebo (for dupilumab) (DRUG), Mometasone furoate nasal spray (DRUG).

Who is sponsoring clinical trial NCT01920893?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.