Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Conditions
Interventions
Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
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