Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
NCT ID: NCT04959448
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
717 participants
OBSERVATIONAL
2021-08-12
2027-03-25
Brief Summary
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* To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.
* To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities
The secondary objectives of the study are:
* To characterize real-world utilization of DUPIXENT® for patients with CRSwNP
* To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP
* To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DUPIXENT®
No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to comply with clinic visits and study-related procedures as per protocol
* Provide informed consent signed by study patient or legally acceptable representative
* Able to understand and complete study-related questionnaires as per protocol
Exclusion Criteria
* Any previous treatment with DUPIXENT® for any condition
* Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol
* Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Excel ENT of Alabama
Birmingham, Alabama, United States
Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates
Scottsdale, Arizona, United States
The Allergy and Rheumatology Medical Clinic
La Jolla, California, United States
ARK Clinical Research
Long Beach, California, United States
Scripps Health - Scripps Clinic Carmel Valley
San Diego, California, United States
Breathe Clear Institute
Torrance, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
AADRS Clincial Research Center
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
Damask Physicians Group
Lake Mary, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
IACT Health
Columbus, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM
Chicago, Illinois, United States
Asthma & Allergy Center of Chicago
Oak Park, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
John Hopkins University School Of Medicine
Baltimore, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan, Michigan Medicine Pulmonary Clinic
Ann Arbor, Michigan, United States
Allergy & Asthma Center of Minnesota - Allergology
Maplewood, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Atlantic Research Center LLC
Ocean City, New Jersey, United States
Northwell Health
Great Neck, New York, United States
Montefiore Medical Center
New York, New York, United States
Rochester Regional Health System
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Allergy Partners of the Triangle
Raleigh, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Essential Medical Research
Tulsa, Oklahoma, United States
Asthma, Nasal Disease & Allergy Research Center of New England
East Providence, Rhode Island, United States
Allergy and Asthma Physicians of RI
Lincoln, Rhode Island, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
ADAC research, PA
Greenville, South Carolina, United States
Spartanburg Ear, Nose & Throat Clinical
Spartanburg, South Carolina, United States
ENT & Allergy Partners
Summerville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
STAAMP Research
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
University of Virginia Health System (UVA)
Charlottesville, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Richmond Ear Nose & Throat
Richmond, Virginia, United States
The Vancouver Clinic
Vancouver, Washington, United States
ENT Clinic Sinus Center, St. Paul's Hospital
Vancouver, British Columbia, Canada
Dr. Richard Gall Med Corp
Winnipeg, Manitoba, Canada
Toronto Allergy & Asthma Clinic-Pulmonology
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Hopital Du Saint-Sacrement
Québec, , Canada
University Hospital Mannheim - Dermatology, Venerology, Allergology
Mannheim, Baden-Wurttemberg, Germany
Charité
Berlin, Brandenburg, Germany
Oberhavelkliniken Hennigsdorf
Hennigsdorf, Brandenburg, Germany
Zentrum für Rhinologie
Wiesbaden, Hesse, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
University Hospital Münster
Münster, North Rhine-Westphalia, Germany
Praxis Dr. Yury Yarin
Dresden, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero Universitara Policlinico di Catania
Catania, Sicily, Italy
Universita Degli Studi di Pisa Ospedale di Cisanello Pisa
Pisa, Tuscany, Italy
Azienda Ospedaliero Universitaria Senese
Siena, Tuscany, Italy
AOU di Padova
Padua, Veneto, Italy
Università Degli Studi Magna Graecia di Catanzaro
Catanzaro, , Italy
ENT Clinic San Martino Hospital
Genova, , Italy
Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, , Italy
Fondazione universitaria Policlinico A. Gemelli
Rome, , Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, , Italy
University of Fukui Hospital - Otorhinolaryngology
Yoshida-gun, Hukui, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan
Nagaoka Red Cross Hospital - Otorhinolaryngology
Nagaoka, Niigita, Japan
Osaka Haibikino Medical Center
Habikino, Osaka, Japan
Tokyo Kyosai Hospital
Meguro-Ku, Tokyo, Japan
Matsuwaki Clinic Shinagawa
Shinagawa-Ku, Tokyo, Japan
Kyoto Nose & Allergy Clinic
Kyoto, , Japan
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands
Amsterdam UMC location AMC
Amsterdam, North Holland, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Countries
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References
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Siddiqui S, Bachert C, Chaker AM, Han JK, Hellings PW, Peters AT, Heffler E, Kamat S, Zhang H, Nash S, Khan AH, De Prado Gomez L, Jacob-Nara JA, Rowe PJ, Deniz Y. AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps. ERJ Open Res. 2022 Nov 28;8(4):00085-2022. doi: 10.1183/23120541.00085-2022. eCollection 2022 Oct.
Related Links
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THE AROMA LANDMARK REGISTRY: A GLOBAL STUDY INVOLVING AN APPROVED INJECTABLE MEDICINE FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS
Other Identifiers
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42822
Identifier Type: REGISTRY
Identifier Source: secondary_id
R668-cSNP-2072
Identifier Type: -
Identifier Source: org_study_id
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