Active, not recruitingNo phase

Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Key facts

Who runs it: Regeneron Pharmaceuticals
Where: Ann Arbor, Atlanta, Baltimore, Birmingham, Boise, Boston, Charleston, Charlottesville, Chicago, Cincinnati, Columbia, Columbus, Coral Gables, Durham, East Providence, Gainesville, Great Neck, Greenville, Indianapolis, La Jolla, Lake Mary, Layton, Lincoln, Long Beach, Maplewood, Nashville, New York, Norfolk, Oak Park, Ocean City, Omaha, Raleigh, Richmond, Rochester, San Antonio, San Diego, Scottsdale, Spartanburg, Summerville, Tampa, Torrance, Tulsa, Vancouver, Walnut Creek, and Winston-Salem, United StatesSee the 48 sitesAlso in 5 other countries, 33 sites
Trial code: NCT04959448
Status: Active, not recruiting
People taking part: 717 people enrolled
Started: 12 Aug 2021
Expected to end: 25 Mar 2027
Type of study: Observational
Treatments tested: DUPIXENT®
Record updated: 13 July 2026

Who can take part

Age: 18 years and older
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
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

Who cannot take part

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
Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
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

Where in United States

Also in 5 other countries, 33 sites

University of Michigan, Michigan Medicine Pulmonary ClinicAnn Arbor, United States
Emory University Hospital MidtownAtlanta, United States
John Hopkins University School of MedicineBaltimore, United States
Excel ENT of AlabamaBirmingham, United States
Treasure Valley Medical ResearchBoise, United States
Brigham & Women's HospitalBoston, United States
Medical University of South CarolinaCharleston, United States
University of Virginia Health System (UVA)Charlottesville, United States
Northwestern University Feinberg School of MedicineChicago, United States
The University of Chicago Medical Center (UCMC) Duchossois Center for Advanced Medicine (DCAM)Chicago, United States
University of IllinoisChicago, United States
University of Cincinnati College of MedicineCincinnati, United States
University of MissouriColumbia, United States
IACT HealthColumbus, United States
AADRS Clincial Research CenterCoral Gables, United States
Duke University Medical CenterDurham, United States
Asthma, Nasal Disease & Allergy Research Center of New EnglandEast Providence, United States
University of FloridaGainesville, United States
Northwell HealthGreat Neck, United States
ADAC Research PAGreenville, United States
Indiana University HealthIndianapolis, United States
The Allergy and Rheumatology Medical ClinicLa Jolla, United States
Damask Physicians GroupLake Mary, United States
Tanner ClinicLayton, United States
Allergy and Asthma Physicians of RILincoln, United States
Ark Clinical ResearchLong Beach, United States
Allergy & Asthma Center of Minnesota - AllergologyMaplewood, United States
Vanderbilt University Medical CenterNashville, United States
Montefiore Medical CenterNew York, United States
Eastern Virginia Medical SchoolNorfolk, United States
Asthma & Allergy Center of ChicagoOak Park, United States
Atlantic Research Center, LLCOcean City, United States
University of Nebraska Medical CenterOmaha, United States
Allergy Partners of the TriangleRaleigh, United States
Richmond Ear Nose & ThroatRichmond, United States
Rochester Regional Health SystemRochester, United States
University of Rochester Medical CenterRochester, United States
STAAMP ResearchSan Antonio, United States
Scripps Health - Scripps Clinic Carmel ValleySan Diego, United States
Medical Research of Arizona, a division of Allergy, Asthma & Immunology AssociatesScottsdale, United States
Spartanburg Ear, Nose & Throat ClinicalSpartanburg, United States
ENT & Allergy PartnersSummerville, United States
University of South FloridaTampa, United States
Breathe Clear InstituteTorrance, United States
Essential Medical ResearchTulsa, United States
The Vancouver ClinicVancouver, United States
Allergy & Asthma Clinical ResearchWalnut Creek, United States
Wake Forest Baptist HealthWinston-Salem, United States

About the trial

What the trial wants to find out

The primary objectives of the study are:

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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