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

Study identification

• EU PAS number:
  EUPAS41565
• Study ID:
  42822
• Official title and acronym:
  Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (AROMA)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  Italy

  Japan

  Netherlands

  United States
• Study description:
  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
• Study status:
  Ongoing

Research institutions and networks

Institutions

Regeneron Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual:09/06/2021

Study start date

Planned:13/08/2021

Actual:12/08/2021

Data analysis start date

Planned:26/04/2027

Date of final study report

Planned:07/06/2027

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Regeneron Pharmaceuticals, Inc., Sanofi

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

R668-cSNP-2072,NCT04959448