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A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

NCT02912468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2019-07-25

Study results available
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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.

Conditions

  • Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Interventions

DRUG

Dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Mometasone furoate 50 micrograms

Pharmaceutical form: Suspension (Nasal spray) Route of administration: Intranasal

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2018-07-05
Completion
2018-07-05

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912468 on ClinicalTrials.gov