NCT04959448

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

Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 717 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Rhinosinusitis With Nasal Polyposis

Interventions

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

Timeline

• Start date: 2021-08-12
• Primary completion: 2027-03-25
• Completion: 2027-03-25
• First posted: 2021-07-13
• Last updated: 2025-07-18

Locations

81 sites across 6 countries: United States, Canada, Germany, Italy, Japan, Netherlands

Regulatory

• FDA-regulated drug study