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

NCT04959448

Active Not RecruitingN/A

Sponsor: Regeneron Pharmaceuticals

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Interventions: DUPIXENT®

Countries: United States, Canada, Germany, Italy, Japan, Netherlands

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (81)
  • Birmingham, Alabama, United States
  • Scottsdale, Arizona, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • San Diego, California, United States
  • Torrance, California, United States
  • Walnut Creek, California, United States
  • Coral Gables, Florida, United States
  • Gainesville, Florida, United States
  • Lake Mary, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Columbus, Georgia, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Oak Park, Illinois, United States
  • Indianapolis, Indiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Maplewood, Minnesota, United States
  • Columbia, Missouri, United States
  • Omaha, Nebraska, United States
  • Ocean City, New Jersey, United States
  • Great Neck, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Rochester, New York, United States
  • + 51 more on CT.gov