RecruitingPhase 4NCT06572228

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

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

Sponsor

Regeneron Pharmaceuticals

Enrollment

250 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma

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

Eligibility

Min Age: 12 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for people with asthma that is not well controlled on their current inhaler combination. It tests whether adding a biologic drug called dupilumab works better than simply increasing the dose of the inhaled steroid. **You may be eligible if...** - You have had asthma for at least 12 months - You are currently on a medium-dose inhaled steroid plus long-acting bronchodilator for at least 3 months - Your asthma is still not well controlled despite this treatment - Your breathing tests show reversibility with a rescue inhaler - You have been taking your medication as prescribed at least 80% of the time **You may NOT be eligible if...** - Your asthma is well controlled on your current treatment - You require more than 3 controller medications - You have a condition that would make one of the study drugs unsafe for you - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdupilumab

Administered by subcutaneous (SC) injection

DRUGMatching Placebo

Administered by SC injection

DRUGICS/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, LLC

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

Endeavor Health, Skokie Campus

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 Hospital

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

View Full Details on ClinicalTrials.gov

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NCT06572228

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