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COMPLETED
NCT04678856
PHASE2

Dupilumab in CRSsNP

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2020-12-02

Completion Date

2024-01-29

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Locations (58)

Sacramento Ear, Nose & Throat Site Number : 8400010

Roseville, California, United States

Bensch Clinical Research LLC Site Number : 8400015

Stockton, California, United States

Colorado Allergy and Asthma Centers, PC Site Number : 8400003

Denver, Colorado, United States

University of Missouri Health System Site Number : 8400016

Columbia, Missouri, United States

Nebraska Medical Research Institute Site Number : 8400007

Papillion, Nebraska, United States

Optimed Research, LTD Site Number : 8400017

Columbus, Ohio, United States

Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004

Tulsa, Oklahoma, United States

Essential Medical Research, LLC Site Number : 8400014

Tulsa, Oklahoma, United States

Pharmaceutical Research & Consulting, Inc. Site Number : 8400006

Dallas, Texas, United States

Alamo ENT Associates Site Number : 8400021

San Antonio, Texas, United States

Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009

Norfolk, Virginia, United States

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320003

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number : 0320001

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number : 0560002

Ghent, Belgium

Investigational Site Number : 0560001

Leuven, Belgium

Investigational Site Number : 1240013

Vancouver, British Columbia, Canada

Investigational Site Number : 1240010

Hamilton, Ontario, Canada

Investigational Site Number : 1240007

Kingston, Ontario, Canada

Investigational Site Number : 1240016

London, Ontario, Canada

Investigational Site Number : 1240001

Montreal, Quebec, Canada

Investigational Site Number : 1240012

Montreal, Quebec, Canada

Investigational Site Number : 1240002

Trois-Rivières, Quebec, Canada

Investigational Site Number : 1240005

Québec, Canada

Investigational Site Number : 1240003

Québec, Canada

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 1560005

Changchun, China

Investigational Site Number : 1560013

Changsha, China

Investigational Site Number : 1560010

Chongqing, China

Investigational Site Number : 1560006

Shanghai, China

Investigational Site Number : 1560008

Yantai, China

Investigational Site Number : 3480004

Budapest, Hungary

Investigational Site Number : 3480001

Pécs, Hungary

Investigational Site Number : 6200002

Aveiro, Portugal

Investigational Site Number : 6200001

Guimarães, Portugal

Investigational Site Number : 6200003

Matosinhos Municipality, Portugal

Investigational Site Number : 6430005

Moscow, Russia

Investigational Site Number : 6430002

Saint Petersburg, Russia

Investigational Site Number : 6430003

Saint Petersburg, Russia

Investigational Site Number : 6430001

Stavropol, Russia

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240002

Seville, Andalusia, Spain

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240007

Santander, Cantabria, Spain

Investigational Site Number : 7240004

Jerez de la Frontera, Cádiz, Spain

Investigational Site Number : 7240009

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240005

Madrid / Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240008

Pamplona, Navarre, Spain

Investigational Site Number : 7240010

Madrid, Spain

Investigational Site Number : 7520001

Stockholm, Sweden

Investigational Site Number : 8040005

Dnipro, Ukraine

Investigational Site Number : 8040001

Ivano-Frankivsk, Ukraine

Investigational Site Number : 8040004

Kharkiv, Ukraine

Investigational Site Number : 8040008

Kyiv, Ukraine

Investigational Site Number : 8040002

Kyiv, Ukraine

Investigational Site Number : 8040007

Kyiv, Ukraine