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
NCT ID: NCT06572228
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2024-08-26
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dupilumab + ICS/LABA
Randomized 1:1
dupilumab
Administered by subcutaneous (SC) injection
ICS/LABA
Administered at a blinded dose
Placebo + ICS/LABA
Randomized 1:1
Matching Placebo
Administered by SC injection
ICS/LABA
Administered at a blinded dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dupilumab
Administered by subcutaneous (SC) injection
Matching Placebo
Administered by SC injection
ICS/LABA
Administered at a blinded dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Existing treatment with medium dose ICS/LABA (\>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
4. Pre-bronchodilator FEV1, as defined in the protocol
5. Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol
6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
7. ACQ-5 score ≥1.5 at screening (visit 1)
8. History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
9. Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (\~90% of population), as defined in the protocol
Exclusion Criteria
2. Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging \[MRI\]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)
3. A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol
4. Weight is less than 30 kilograms
5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
6. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol
7. Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period
12 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-510458-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
R668-AS-2373
Identifier Type: -
Identifier Source: org_study_id