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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: Completed Phase 2 study, sponsored by Sanofi.

NCT01920893 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.

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
Sanofi

713 total trials

What the finished NCT01920893 record still lists

NCT01920893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 3 interventions - of which Dupilumab is the first listed.

NCT01920893 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01920893's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01920893, the US trial registry maintained by the National Library of Medicine. NCT01920893 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.