CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Placebo (for dupilumab) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01920893
NCT01920893Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

Sanofi·interventional·Posted Aug 12, 2013·Updated Jun 26, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo (for dupilumab), Dupilumab, and 1 other intervention for Nasal Polyps. Completed, enrolled 60 participants across 14 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
CountriesBelgium, Spain, Sweden, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 12, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.9 years ago

Interventions

Placebo (for dupilumab)drug

Solution for injection; Subcutaneous injection.

Dupilumabdrug

Solution for injection; Subcutaneous injection.

Mometasone furoate nasal spraydrug

Nasal spray, 2 actuations in each nostril twice daily.