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

NCT04959448 | Active Not Recruiting FDA Drug

• 2 other identifiers: R668-cSNP-207242822
• Study Type: observational
• Target: 717
• Locations: 6 countries
• Sites: 81

Brief 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

Keywords

CRSwNP

Outcome Measures

Primary Outcomes (2)

• Baseline Patient Characteristics

  Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information.

  Baseline up to 3 years

• Baseline Disease Characteristics

  Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables.

  Baseline up to 3 years

Secondary Outcomes (21)

• DUPIXENT® Treatment Characteristics

  Baseline up to 3 years

• CRSwNP Treatment Characteristics

  Baseline up to 3 years

• Incidence and severity of adverse events (AEs)

  Baseline up to 3 years

• Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])

  Baseline up to 3 years

• Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score

  Baseline up to 3 years

Interventions

DUPIXENT® DRUG

No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.

Also known as: dupilumab, REGN668, SAR231893

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are initiating treatment with DUPIXENT® for CRSwNP according to the country-specific prescribing information.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (81)

Excel ENT of Alabama

Birmingham, Alabama, 35244, United States

Location

Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

The Allergy and Rheumatology Medical Clinic

La Jolla, California, 92037, United States

Location

ARK Clinical Research

Long Beach, California, 90806, United States

Location

Scripps Health - Scripps Clinic Carmel Valley

San Diego, California, 92130, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

AADRS Clincial Research Center

Coral Gables, Florida, 33134, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Damask Physicians Group

Lake Mary, Florida, 32746, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

IACT Health

Columbus, Georgia, 31904, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM

Chicago, Illinois, 60637, United States

Location

Asthma & Allergy Center of Chicago

Oak Park, Illinois, 60301, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University School Of Medicine

Baltimore, Maryland, 21224, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan, Michigan Medicine Pulmonary Clinic

Ann Arbor, Michigan, 48109-5000, United States

Location

Allergy & Asthma Center of Minnesota - Allergology

Maplewood, Minnesota, 55109, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Atlantic Research Center LLC

Ocean City, New Jersey, 07712, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Montefiore Medical Center

New York, New York, 10461, United States

Location

Rochester Regional Health System

Rochester, New York, 14626, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Allergy Partners of the Triangle

Raleigh, North Carolina, 27607, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45229, United States

Location

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

Location

Asthma, Nasal Disease & Allergy Research Center of New England

East Providence, Rhode Island, 02914, United States

Location

Allergy and Asthma Physicians of RI

Lincoln, Rhode Island, 02865, United States

Location

Medical University Of South Carolina

Charleston, South Carolina, 29425, United States

Location

ADAC research, PA

Greenville, South Carolina, 29607, United States

Location

Spartanburg Ear, Nose & Throat Clinical

Spartanburg, South Carolina, 29303, United States

Location

ENT & Allergy Partners

Summerville, South Carolina, 29486, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

STAAMP Research

San Antonio, Texas, 78229, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

University of Virginia Health System (UVA)

Charlottesville, Virginia, 22903, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Richmond Ear Nose & Throat

Richmond, Virginia, 23235, United States

Location

The Vancouver Clinic

Vancouver, Washington, 98664, United States

Location

ENT Clinic Sinus Center, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Dr. Richard Gall Med Corp

Winnipeg, Manitoba, R3P1C7, Canada

Location

Toronto Allergy & Asthma Clinic-Pulmonology

Toronto, Ontario, M5G 1E2, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Hopital Du Saint-Sacrement

Québec, G1S 4L8, Canada

Location

University Hospital Mannheim - Dermatology, Venerology, Allergology

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Charité

Berlin, Brandenburg, 10117, Germany

Location

Oberhavelkliniken Hennigsdorf

Hennigsdorf, Brandenburg, 16761, Germany

Location

Zentrum für Rhinologie

Wiesbaden, Hesse, 65183, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Praxis Dr. Yury Yarin

Dresden, Saxony, 01139, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07740, Germany

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero Universitara Policlinico di Catania

Catania, Sicily, 95125, Italy

Location

Universita Degli Studi di Pisa Ospedale di Cisanello Pisa

Pisa, Tuscany, 56100, Italy

Location

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, 53100, Italy

Location

AOU di Padova

Padua, Veneto, 35128, Italy

Location

Università Degli Studi Magna Graecia di Catanzaro

Catanzaro, 88100, Italy

Location

ENT Clinic San Martino Hospital

Genova, 16126, Italy

Location

Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"

Rome, 00161, Italy

Location

Fondazione universitaria Policlinico A. Gemelli

Rome, 00168, Italy

Location

Azienda Ospedaliero Universitaria di Sassari

Sassari, 07100, Italy

Location

University of Fukui Hospital - Otorhinolaryngology

Yoshida-gun, Hukui, 910-1193, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

Nagaoka Red Cross Hospital - Otorhinolaryngology

Nagaoka, Niigita, 940-2085, Japan

Location

Osaka Haibikino Medical Center

Habikino, Osaka, 583-8588, Japan

Location

Tokyo Kyosai Hospital

Meguro-Ku, Tokyo, 153-8934, Japan

Location

Matsuwaki Clinic Shinagawa

Shinagawa-Ku, Tokyo, 141-0001, Japan

Location

Kyoto Nose & Allergy Clinic

Kyoto, 600-8216, Japan

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091 AC, Netherlands

Location

Amsterdam UMC location AMC

Amsterdam, North Holland, 1105, Netherlands

Location

Alrijne Ziekenhuis

Leiderdorp, South Holland, 2353, Netherlands

Location

Related Publications (1)

• Siddiqui S, Bachert C, Chaker AM, Han JK, Hellings PW, Peters AT, Heffler E, Kamat S, Zhang H, Nash S, Khan AH, De Prado Gomez L, Jacob-Nara JA, Rowe PJ, Deniz Y. AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps. ERJ Open Res. 2022 Nov 28;8(4):00085-2022. doi: 10.1183/23120541.00085-2022. eCollection 2022 Oct.

  PMID: 36451848 DERIVED

Related Links

• THE AROMA LANDMARK REGISTRY: A GLOBAL STUDY INVOLVING AN APPROVED INJECTABLE MEDICINE FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

MeSH Terms

Interventions

dupilumab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 13, 2021
• Study Start: August 12, 2021
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

DE (8); CA (5); US (48); IT (10); JP (7); NL (3)