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Chronic Rhinosinusitis With Nasal Pol...

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

Sponsored by Regeneron Pharmaceuticals

About this trial

Last updated a year ago

Study ID

R668-cSNP-2072

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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

What are the Participation Requirements?

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

Location

Status