Registry of Asthma Patients Initiating DUPIXENT®

NCT04287621 | Active Not Recruiting FDA Drug

• 3 other identifiers: R668-AS-188546244EUPAS41963
• Study Type: observational
• Target: 718
• Locations: 10 countries
• Sites: 128

Brief Summary

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of:

• Patient demographics (eg, gender, age, and race)
• Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) The secondary objectives of the study are:
• To characterize real-world use patterns of DUPIXENT® for asthma
• To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
• To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
• To collect long-term safety data on study participants in the real-world setting

Conditions

Asthma

Keywords

Primary Indication of Asthma

Outcome Measures

Primary Outcomes (2)

• Demography

  Including gender, age, race

  At Baseline

• Baseline Characteristics

  Including prior medications and procedures, medical history, asthma history, weight, height

  At Baseline

Secondary Outcomes (14)

• Baseline Treatment Characteristics

  At Baseline

• Incidence of adverse events (AEs)

  Baseline up to 3 years

• Physician Assessment: - Spirometry

  Baseline up to 3 years

• Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)

  Baseline up to 3 Years

• Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)

  Baseline up to 3 Years

Interventions

DUPIXENT® DRUG

There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.

Also known as: dupilumab, REGN668, SAR231893

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for asthma according to the country-specific prescribing information.

You may qualify if:

• Willing and able to comply with the required clinic visits, study procedures and assessments
• Able to understand and complete study-related questionnaires
• Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
• Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information

You may not qualify if:

• Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
• Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
• Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (128)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

Arizona Allergy & Immunology Research

Gilbert, Arizona, 85234, United States

Location

Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.

Scottsdale, Arizona, 85251, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Riviera Allergy Medical Center

Redondo Beach, California, 90277, United States

Location

Allergy & Asthma Medical Group and Research, A PC

San Diego, California, 92123, United States

Location

Bensch Clinical Research, LLC

Stockton, California, 95207, United States

Location

Allianz Research Institute, Inc.

Westminster, California, 92683, United States

Location

Global Research Solutions

Hollywood, Florida, 33021, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Clinical Research Specialists, LLC

Kissimmee, Florida, 34746, United States

Location

Kratz Allergy & Asthma

Port Richey, Florida, 34653, United States

Location

GCP, Global Clinical Professionals

St. Petersburg, Florida, 33702, United States

Location

Allergy & Asthma Diagnostic Treatment Center

Tallahassee, Florida, 32308, United States

Location

Omni Allergy

Atlanta, Georgia, 30342, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

IACT Health Southeast Lung Associates

Rincon, Georgia, 31326, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Northwestern Medical Group Allergy & Immunology Clinic

Chicago, Illinois, 60611, United States

Location

The University of Chicago

Chicago, Illinois, 60634, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Asthma and Allergy Center of Chicago

Oak Park, Illinois, 60301, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Velocity Clinical Research

Overland Park, Kansas, 66210, United States

Location

Dr. Henry J. Kanarek Allergy, Asthma & Immunology

Overland Park, Kansas, 66211, United States

Location

Family Allergy and Asthma

Louisville, Kentucky, 40291, United States

Location

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, 42301, United States

Location

Schreiber Allergy

Rockville, Maryland, 20850, United States

Location

Virgo-Carter Pediatrics

Silver Spring, Maryland, 20910, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

University of Michigan Allergy Specialty Clinic and Food Allergy Clinic

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Allergy and Asthma Center of Minnesota

Maplewood, Minnesota, 55109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

ENT & Allergy Center of Missouri

Columbia, Missouri, 65201, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Nebraska Medical Research Institute, Inc.

Bellevue, Nebraska, 68123, United States

Location

CHI Health Clinic Pulmonary

Omaha, Nebraska, 68124, United States

Location

Ocean Allergy & Respiratory Research Center

Brick, New Jersey, 08724, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712, United States

Location

A Atat Progressive Pulmonary & Sleep Medicine

Brooklyn, New York, 11209, United States

Location

New York Allergy and Sinus Centers

Glendale, New York, 11385, United States

Location

Northwell Health Division of Allergy & Immunology

Great Neck, New York, 11021, United States

Location

Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset

Manhasset, New York, 11030, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

Summit Health

Oakland Gardens, New York, 11364, United States

Location

RRH Allergy, Immunology & Rheumatology

Rochester, New York, 14607, United States

Location

Allergy & Asthma Care of LI

Rockville Centre, New York, 11570, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Allergy Partners of the Triangle

Cary, North Carolina, 27518, United States

Location

UNC Children's Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Javara Inc. and Tryon Medical Partners, PLLC

Charlotte, North Carolina, 28210, United States

Location

Airways Clinical Research Center

Winston-Salem, North Carolina, 27104, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45220, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

Oklahoma City, Oklahoma, 73131, United States

Location

Portland Research

Happy Valley, Oregon, 97086, United States

Location

Allergy and Asthma Specialists, P.C.

Blue Bell, Pennsylvania, 19422, United States

Location

Columbo Asthma, Allergy and Immunology, LLC

Bryn Mawr, Pennsylvania, 19010, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Asthma, Nasal Disease & Allergy Research Center of New England

East Providence, Rhode Island, 02914, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

Charleston ENT Associates, LLC

Summerville, South Carolina, 29486, United States

Location

Precision Research Institute, LLC

Houston, Texas, 77029, United States

Location

STAAMP Research, LLC

San Antonio, Texas, 78229, United States

Location

Element Research Group

San Antonio, Texas, 78258, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

The University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

BLC Clinical Research

Burlington, Ontario, L7N 3V2, Canada

Location

Evidence Based Medical Educator Inc.

Toronto, Ontario, M5G 1E2, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

Location

Dr. Syeed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval

Québec, G1V 4G5, Canada

Location

Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling

Vejle, 7100, Denmark

Location

Centre Hospitalier du Pays d'Aix - Maladies Respiratoires

Aix-en-Provence, 13100, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand

Dijon, 21079, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Hôpital Nord

Marseille, 13015, France

Location

Hopital Jacques Monod

Montivilliers, 76290, France

Location

Fondazione Salvatore Maugeri

Bari, Apulia, 70020, Italy

Location

Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco

Milan, Lombardy, 20154, Italy

Location

Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

Location

La Fondazione IRCCS Policlinico "San Matteo"

Pavia, Lombardy, 27100, Italy

Location

Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.

Rozzano, Lombardy, 20089, Italy

Location

Azienda Sanitaria Locale Salerno

Battipaglia, Salerno, 84091, Italy

Location

Istituto Nazionale di Riposo e Cura per Anziani

Ancona, The Marches, 60127, Italy

Location

Hansaki Clinic

Kiyosu-shi, Aichi-ken, 452-0001, Japan

Location

Hokkaido University Hospital

Kita-ku, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Dokkyo Medical University Hospital

Mibu, Tochigi, 321-0293, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-0033, Japan

Location

Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo

Chuo-ku, Tokyo, 104-0031, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Incorporated Medical Corporation, Jinyukai, Jinyu Clinic

Nakano Ku, Tokyo, 164-0012, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

The Fraternity Memorial Hospital

Sumida-ku, Tokyo, 130-8587, Japan

Location

Agosto Allergy and Immunology

Cayey, 00736, Puerto Rico

Location

CardioPulmonary Research CSP

Guaynabo, 00968, Puerto Rico

Location

Instituto Pulmonary Diseases Torre Medica San Lucas

Ponce, 00731, Puerto Rico

Location

Rafael H Zaragoza - Urdaz

San Juan, 00918, Puerto Rico

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

University of Puerto Rico Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Catalonia, 08916, Spain

Location

Complexo Hospialario Universitario A Coruña

A Coruña, Galicia, 15006, Spain

Location

Fysikalisk Medicin

Lidingö, Stockholms Län [se-01], SE-181 58, Sweden

Location

Pennine Acute Hospitals NHS Trust

Manchester, Greater Manchester, M8 5RB, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

Royal Devon University Healthcare NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

St. James Hospital Leeds

Leeds, LS9 7TF, United Kingdom

Location

Glenfield General Hospital

Leicester, LE3 9QP, United Kingdom

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9QZ, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PD, United Kingdom

Location

Related Publications (1)

• Gall R, Jain N, Soong W, Settipane RA, Xia C, Zhang Y, Haselkorn T, Jacob-Nara JA, Siddiqui S. Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry. Adv Ther. 2023 Mar;40(3):1292-1298. doi: 10.1007/s12325-022-02399-5. Epub 2023 Jan 10.

  PMID: 36626107 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 156 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: March 2, 2020
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (11); US (73); FR (6); PR (6); JP (12); DK (1); CA (7); IT (7); ES (4); SE (1)