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Active Not Recruiting NCT04959448

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

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 717
Sponsor: Regeneron Pharmaceuticals

Location: Excel ENT of Alabama Birmingham Alabama

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04959448). StuddyBuddy aggregates publicly available trial information.