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Clinical Trials in the USA / NCT04959448
Active, not recruiting Observational

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

NCT04959448 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Observational
Started
2021-08-12
Last updated
2026-07-13

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyposis

Investigational drug(s) / intervention(s)

DUPIXENT® →

DUPIXENT®: No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.

Study summary

The primary objectives of the study are:

* 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information * 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

Primary outcome measure(s)

Trial sites (81)

FacilityCityRegionStatus
Excel ENT of Alabama Birmingham Alabama
Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates Scottsdale Arizona
The Allergy and Rheumatology Medical Clinic La Jolla California
ARK Clinical Research Long Beach California
Scripps Health - Scripps Clinic Carmel Valley San Diego California
Breathe Clear Institute Torrance California
Allergy & Asthma Clinical Research Walnut Creek California
AADRS Clincial Research Center Coral Gables Florida
University of Florida Gainesville Florida
Damask Physicians Group Lake Mary Florida
University of South Florida Tampa Florida
Emory University Hospital Midtown Atlanta Georgia
IACT Health Columbus Georgia
Treasure Valley Medical Research Boise Idaho
Northwestern University Feinberg School of Medicine Chicago Illinois
University of Illinois Chicago Illinois
The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM Chicago Illinois
Asthma & Allergy Center of Chicago Oak Park Illinois
Indiana University Health Indianapolis Indiana
John Hopkins University School Of Medicine Baltimore Maryland
Brigham & Women's Hospital Boston Massachusetts
University of Michigan, Michigan Medicine Pulmonary Clinic Ann Arbor Michigan
Allergy & Asthma Center of Minnesota - Allergology Maplewood Minnesota
University of Missouri Columbia Missouri
University of Nebraska Medical Center Omaha Nebraska
Atlantic Research Center LLC Ocean City New Jersey
Northwell Health Great Neck New York
Montefiore Medical Center New York New York
Rochester Regional Health System Rochester New York
University of Rochester Medical Center Rochester New York
Duke University Medical Center Durham North Carolina
Allergy Partners of the Triangle Raleigh North Carolina
Wake Forest Baptist Health Winston-Salem North Carolina
University of Cincinnati College of Medicine Cincinnati Ohio
Essential Medical Research Tulsa Oklahoma
Asthma, Nasal Disease & Allergy Research Center of New England East Providence Rhode Island
Allergy and Asthma Physicians of RI Lincoln Rhode Island
Medical University Of South Carolina Charleston South Carolina
ADAC research, PA Greenville South Carolina
Spartanburg Ear, Nose & Throat Clinical Spartanburg South Carolina

+ 41 more sites — see the full list on the official registry below.

More Regeneron Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04959448 on ClinicalTrials.gov ↗ ← All trials in the USA