Registry of Asthma Patients Initiating DUPIXENT®

NCT ID: NCT04287621

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

718 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2026-05-13

Brief Summary

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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

Detailed Description

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3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DUPIXENT®

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.

Intervention Type DRUG

Other Intervention Names

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dupilumab REGN668 SAR231893

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Site Status

Arizona Allergy & Immunology Research

Gilbert, Arizona, United States

Site Status

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

Scottsdale, Arizona, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Riviera Allergy Medical Center

Redondo Beach, California, United States

Site Status

Allergy & Asthma Medical Group and Research, A PC

San Diego, California, United States

Site Status

Bensch Clinical Research, LLC

Stockton, California, United States

Site Status

Allianz Research Institute, Inc.

Westminster, California, United States

Site Status

Global Research Solutions

Hollywood, Florida, United States

Site Status

Memorial Healthcare System

Hollywood, Florida, United States

Site Status

Clinical Research Specialists, LLC

Kissimmee, Florida, United States

Site Status

Kratz Allergy & Asthma

Port Richey, Florida, United States

Site Status

GCP, Global Clinical Professionals

St. Petersburg, Florida, United States

Site Status

Allergy & Asthma Diagnostic Treatment Center

Tallahassee, Florida, United States

Site Status

Omni Allergy

Atlanta, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

IACT Health Southeast Lung Associates

Rincon, Georgia, United States

Site Status

Treasure Valley Medical Research

Boise, Idaho, United States

Site Status

Northwestern Medical Group Allergy & Immunology Clinic

Chicago, Illinois, United States

Site Status

The University of Chicago

Chicago, Illinois, United States

Site Status

NorthShore University Health System

Evanston, Illinois, United States

Site Status

Asthma and Allergy Center of Chicago

Oak Park, Illinois, United States

Site Status

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Site Status

Velocity Clinical Research

Overland Park, Kansas, United States

Site Status

Dr. Henry J. Kanarek Allergy, Asthma & Immunology

Overland Park, Kansas, United States

Site Status

Family Allergy and Asthma

Louisville, Kentucky, United States

Site Status

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, United States

Site Status

Schreiber Allergy

Rockville, Maryland, United States

Site Status

Virgo-Carter Pediatrics

Silver Spring, Maryland, United States

Site Status

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Site Status

University of Michigan Allergy Specialty Clinic and Food Allergy Clinic

Ann Arbor, Michigan, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Allergy and Asthma Center of Minnesota

Maplewood, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

ENT & Allergy Center of Missouri

Columbia, Missouri, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

The Clinical Research Center, LLC

St Louis, Missouri, United States

Site Status

Nebraska Medical Research Institute, Inc.

Bellevue, Nebraska, United States

Site Status

CHI Health Clinic Pulmonary

Omaha, Nebraska, United States

Site Status

Ocean Allergy & Respiratory Research Center

Brick, New Jersey, United States

Site Status

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

Site Status

A Atat Progressive Pulmonary & Sleep Medicine

Brooklyn, New York, United States

Site Status

New York Allergy and Sinus Centers

Glendale, New York, United States

Site Status

Northwell Health Division of Allergy & Immunology

Great Neck, New York, United States

Site Status

Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset

Manhasset, New York, United States

Site Status

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status

Summit Health

Oakland Gardens, New York, United States

Site Status

RRH Allergy, Immunology & Rheumatology

Rochester, New York, United States

Site Status

Allergy & Asthma Care of LI

Rockville Centre, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Allergy Partners of Western North Carolina

Asheville, North Carolina, United States

Site Status

Allergy Partners of the Triangle

Cary, North Carolina, United States

Site Status

UNC Children's Hospital

Chapel Hill, North Carolina, United States

Site Status

Javara Inc. and Tryon Medical Partners, PLLC

Charlotte, North Carolina, United States

Site Status

Airways Clinical Research Center

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

Oklahoma City, Oklahoma, United States

Site Status

Portland Research

Happy Valley, Oregon, United States

Site Status

Allergy and Asthma Specialists, P.C.

Blue Bell, Pennsylvania, United States

Site Status

Columbo Asthma, Allergy and Immunology, LLC

Bryn Mawr, Pennsylvania, United States

Site Status

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status

Asthma, Nasal Disease & Allergy Research Center of New England

East Providence, Rhode Island, United States

Site Status

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, United States

Site Status

Charleston ENT Associates, LLC

Summerville, South Carolina, United States

Site Status

Precision Research Institute, LLC

Houston, Texas, United States

Site Status

STAAMP Research, LLC

San Antonio, Texas, United States

Site Status

Element Research Group

San Antonio, Texas, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Allergy Associates of Utah

Murray, Utah, United States

Site Status

Seattle Allergy & Asthma Research Institute

Seattle, Washington, United States

Site Status

Gundersen Health System

La Crosse, Wisconsin, United States

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The University of British Columbia

Vancouver, British Columbia, Canada

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

BLC Clinical Research

Burlington, Ontario, Canada

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Evidence Based Medical Educator Inc.

Toronto, Ontario, Canada

Site Status

Inspiration Research Limited

Toronto, Ontario, Canada

Site Status

Dr. Syeed Anees Medicine Professional Corporation

Windsor, Ontario, Canada

Site Status

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

Québec, , Canada

Site Status

Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling

Vejle, , Denmark

Site Status

Centre Hospitalier du Pays d'Aix - Maladies Respiratoires

Aix-en-Provence, , France

Site Status

CHU de Bordeaux

Bordeaux, , France

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

Dijon, , France

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Hôpital de la Croix-Rousse

Lyon, , France

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Hôpital Nord

Marseille, , France

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Hopital Jacques Monod

Montivilliers, , France

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Fondazione Salvatore Maugeri

Bari, Apulia, Italy

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Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco

Milan, Lombardy, Italy

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Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco

Milan, Lombardy, Italy

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La Fondazione IRCCS Policlinico "San Matteo"

Pavia, Lombardy, Italy

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

Rozzano, Lombardy, Italy

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Azienda Sanitaria Locale Salerno

Battipaglia, Salerno, Italy

Site Status

Istituto Nazionale di Riposo e Cura per Anziani

Ancona, The Marches, Italy

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Hansaki Clinic

Kiyosu-shi, Aichi-ken, Japan

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Hokkaido University Hospital

Kita-ku, Hokkaido, Japan

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Kobe University Hospital

Kobe, Hyōgo, Japan

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Dokkyo Medical University Hospital

Mibu, Tochigi, Japan

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Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

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Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo

Chuo-ku, Tokyo, Japan

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Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

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Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

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Incorporated Medical Corporation, Jinyukai, Jinyu Clinic

Nakano Ku, Tokyo, Japan

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Showa University Hospital

Shinagawa-ku, Tokyo, Japan

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Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

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The Fraternity Memorial Hospital

Sumida-ku, Tokyo, Japan

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Agosto Allergy and Immunology

Cayey, , Puerto Rico

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CardioPulmonary Research CSP

Guaynabo, , Puerto Rico

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Instituto Pulmonary Diseases Torre Medica San Lucas

Ponce, , Puerto Rico

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Rafael H Zaragoza - Urdaz

San Juan, , Puerto Rico

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Fundacion de Investigacion de Diego

San Juan, , Puerto Rico

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University of Puerto Rico Medical Sciences Campus

San Juan, , Puerto Rico

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Hospital De La Santa Creu I Sant Pau

Barcelona, Catalonia, Spain

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Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

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Hospital Germans Trias i Pujol

Barcelona, Catalonia, Spain

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Complexo Hospialario Universitario A Coruña

A Coruña, Galicia, Spain

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Fysikalisk Medicin

Lidingö, Stockholms Län [se-01], Sweden

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Pennine Acute Hospitals NHS Trust

Manchester, Greater Manchester, United Kingdom

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University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

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Royal Devon University Healthcare NHS Foundation Trust

Exeter, , United Kingdom

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Gartnavel General Hospital

Glasgow, , United Kingdom

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St. James Hospital Leeds

Leeds, , United Kingdom

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Glenfield General Hospital

Leicester, , United Kingdom

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St. Bartholomew's Hospital

London, , United Kingdom

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Guy's Hospital

London, , United Kingdom

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Wythenshawe Hospital

Manchester, , United Kingdom

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Freeman Hospital

Newcastle upon Tyne, , United Kingdom

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Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Countries

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United States Canada Denmark France Italy Japan Puerto Rico Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36626107 (View on PubMed)

Other Identifiers

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EUPAS41963

Identifier Type: OTHER

Identifier Source: secondary_id

R668-AS-1885

Identifier Type: -

Identifier Source: org_study_id

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