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Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab
Official title: AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma
Key Details
Gender
All
Age Range
12 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-08-26
Completion Date
2026-12-31
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
dupilumab
Administered by subcutaneous (SC) injection
Matching Placebo
Administered by SC injection
ICS/LABA
Administered at a blinded dose
Locations (84)
Kern Research, Inc
Bakersfield, California, United States
Modena Allergy & Asthma, Inc.
La Jolla, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Ark Clinical Research - Long Beach
Long Beach, California, United States
Newport Native Md, Inc.
Newport Beach, California, United States
Childrens Hospital of Orange County Main Campus
Orange, California, United States
Riviera Allergy Medical Center
Redondo Beach, California, United States
Raffi Tachdjian MD, Inc.
Santa Monica, California, United States
Bensch Clinical Research
Stockton, California, United States
Integrated Research of Inland, Inc.
Upland, California, United States
Allianz Research Institute
Westminster, California, United States
National Jewish Health
Denver, Colorado, United States
St Francis Medical Institute
Clearwater, Florida, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Kissimmee, Florida, United States
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Sneeze Wheeze and Itch Associates
Normal, Illinois, United States
Asthma and Allergy Center of Chicago
River Forest, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Allergy Research
Lexington, Kentucky, United States
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Paul A. Shapero, M.D.
Bangor, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Allergy and Asthma Center of Minnesota
Maplewood, Minnesota, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Montana Medical Research
Missoula, Montana, United States
The Asthma and Allergy Center
Bellevue, Nebraska, United States
Henderson Clinical Trials
Henderson, Nevada, United States
Certified Research Associates
Cortland, New York, United States
New York Medical College
Hawthorne, New York, United States
Northwell Health at ENT & Allergy Associates
New York, New York, United States
Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology
Rochester, New York, United States
Cincinnati Childrens Hospital and Medical Center
Cincinnati, Ohio, United States
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States
University of Pittsburgh Asthma and Environmental Health Lung Institute
Pittsburgh, Pennsylvania, United States
Pulmonology Associates Inc.
Wynnewood, Pennsylvania, United States
Dharma MD PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Baylor College of Medicine - Section of Pulmonary and Critical Care
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas, United States
Lung Sleep Research Institute
North Richland Hills, Texas, United States
South Texas Allergy & Asthma Medical Professionals (STAAMP) Research
San Antonio, Texas, United States
Allergy & Asthma Care of Waco
Waco, Texas, United States
Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Vancouver Clinic
Vancouver, Washington, United States
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
Dynamic Drug Advancement Ltd.
Ajax, Ontario, Canada
Evidence Based Medical Educator Inc.
Toronto, Ontario, Canada
Inspiration Research Limited
Toronto, Ontario, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, Canada
Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval
Québec, Canada
Clinique de Specialisee en Allergie de la Capitale
Québec, Canada
Copenhagen University Hospital - Hvidovre
Hvidovre, Capital Region, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Praxis fur Pneumologie am Duako
Augsburg, Bavaria, Germany
LMU University Hospital Munich
Munich, Bavaria, Germany
IKF Pneumologie Frankfurt GmbH & Co KG
Frankfurt am Main, Hesse, Germany
KPPK Studienzentrum
Koblenz, Rhineland-Palatinate, Germany
Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)
Lübeck, Schleswig-Holstein, Germany
Lungenpraxis Hohenzollerndamm RCMS
Berlin, Germany
POIS Sachsen GmbH iG
Leipzig, Germany
IKF Pneumologie GmbH & Co. KG
Mainz, Germany
Centrum Medyczne All-Med
Krakow, Lesser Poland Voivodeship, Poland
Michał Bogacki - DOBROSTAN
Wroclaw, Lower Silesian Voivodeship, Poland
Diamond Clinic sp zoo
Krakow, Malopolska, Poland
European Trial Group (ETG) Warsaw
Warsaw, Mazovian, Poland
Centrum Medycyny Oddechowej Mroz SJ
Bialystok, Podlaskie Voivodeship, Poland
Allergy Clinic NZOZ Homeo Medicus
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej
Gdansk, Pomeranian Voivodeship, Poland
Lekarze Specjaliści Małolepszy i Partnerzy
Wroclaw, Poland
ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy
Wroclaw, Poland
Allianze pulmonary Research
Guaynabo, Puerto Rico
Fundacion de Investigacion (FDI) Clinical Research
San Juan, Puerto Rico
PRCCI Clinical Research Center
San Juan, Puerto Rico