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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

NCT06572228 · Regeneron Pharmaceuticals
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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
About this study
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Eligibility criteria
Key Inclusion Criteria: 1. Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document 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 Key Exclusion Criteria: 1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments 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 NOTE: Other protocol-defined Inclusion/Exclusion criteria apply
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2024-08-26
Estimated completion: 2026-12-31
Last updated: 2026-02-03
Interventions
Drug: dupilumabDrug: Matching PlaceboDrug: ICS/LABA
Primary outcomes
  • Annualized severe asthma exacerbation rate (Baseline through Week 52)
Sponsor
Regeneron Pharmaceuticals · industry
With: Sanofi
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (84)
Kern Research, IncRecruiting
Bakersfield, California, United States
Modena Allergy & Asthma, Inc.Recruiting
La Jolla, California, United States
Antelope Valley Clinical TrialsRecruiting
Lancaster, California, United States
Ark Clinical Research - Long BeachRecruiting
Long Beach, California, United States
Newport Native Md, Inc.Recruiting
Newport Beach, California, United States
Childrens Hospital of Orange County Main CampusRecruiting
Orange, California, United States
Riviera Allergy Medical CenterWithdrawn
Redondo Beach, California, United States
Raffi Tachdjian MD, Inc.Completed
Santa Monica, California, United States
Bensch Clinical ResearchRecruiting
Stockton, California, United States
Integrated Research of Inland, Inc.Recruiting
Upland, California, United States
Allianz Research InstituteRecruiting
Westminster, California, United States
National Jewish HealthRecruiting
Denver, Colorado, United States
St Francis Medical InstituteRecruiting
Clearwater, Florida, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - CelebrationRecruiting
Kissimmee, Florida, United States
Clinical Site Partners, LLC DBA Flourish ResearchRecruiting
Winter Park, Florida, United States
Treasure Valley Medical ResearchRecruiting
Boise, Idaho, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Sneeze Wheeze and Itch AssociatesRecruiting
Normal, Illinois, United States
Asthma and Allergy Center of ChicagoRecruiting
River Forest, Illinois, United States
NorthShore University Health SystemRecruiting
Skokie, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Bluegrass Allergy ResearchRecruiting
Lexington, Kentucky, United States
Family Allergy and Asthma Research InstituteRecruiting
Louisville, Kentucky, United States
Allergy & Asthma Specialists, P.S.C.Recruiting
Owensboro, Kentucky, United States
Paul A. Shapero, M.D.Recruiting
Bangor, Maine, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Michigan MedicineRecruiting
Ann Arbor, Michigan, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Allergy and Asthma Center of MinnesotaWithdrawn
Maplewood, Minnesota, United States
Clinical Research Institute, Inc.Recruiting
Minneapolis, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Montana Medical ResearchRecruiting
Missoula, Montana, United States
The Asthma and Allergy CenterRecruiting
Bellevue, Nebraska, United States
Henderson Clinical TrialsRecruiting
Henderson, Nevada, United States
Certified Research AssociatesRecruiting
Cortland, New York, United States
New York Medical CollegeRecruiting
Hawthorne, New York, United States
Northwell Health at ENT & Allergy AssociatesRecruiting
New York, New York, United States
Rochester Regional Health - Alexander Park - Allergy, Immunology & RheumatologyRecruiting
Rochester, New York, United States
Cincinnati Childrens Hospital and Medical CenterRecruiting
Cincinnati, Ohio, United States
Allergy Asthma and Clinical Research CenterRecruiting
Oklahoma City, Oklahoma, United States
Clinical Research Associates of Central PACompleted
DuBois, Pennsylvania, United States
University of Pittsburgh Asthma and Environmental Health Lung InstituteRecruiting
Pittsburgh, Pennsylvania, United States
Pulmonology Associates Inc.Recruiting
Wynnewood, Pennsylvania, United States
Dharma MD PA d/b/a Southwest Family Medicine AssociatesRecruiting
Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep MedicineRecruiting
Denison, Texas, United States
Western Sky Medical ResearchRecruiting
El Paso, Texas, United States
Baylor College of Medicine - Section of Pulmonary and Critical CareRecruiting
Houston, Texas, United States
Texas Children's HospitalRecruiting
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center, PARecruiting
McKinney, Texas, United States
Lung Sleep Research InstituteRecruiting
North Richland Hills, Texas, United States
South Texas Allergy & Asthma Medical Professionals (STAAMP) ResearchRecruiting
San Antonio, Texas, United States
Allergy & Asthma Care of WacoRecruiting
Waco, Texas, United States
Intermountain Medical Center - Murray (Pulmonary Medicine)Recruiting
Murray, Utah, United States
Inova Fairfax HospitalRecruiting
Falls Church, Virginia, United States
Vancouver ClinicWithdrawn
Vancouver, Washington, United States
The Lung Centre at Vancouver General HospitalRecruiting
Vancouver, British Columbia, Canada
Dynamic Drug Advancement Ltd.Recruiting
Ajax, Ontario, Canada
Evidence Based Medical Educator Inc.Recruiting
Toronto, Ontario, Canada
Inspiration Research LimitedRecruiting
Toronto, Ontario, Canada
Dr. Syed Anees Medicine Professional CorporationRecruiting
Windsor, Ontario, Canada
Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite LavalRecruiting
Québec, Canada
Clinique de Specialisee en Allergie de la CapitaleRecruiting
Québec, Canada
Copenhagen University Hospital - HvidovreRecruiting
Hvidovre, Capital Region, Denmark
Vejle SygehusRecruiting
Vejle, Region Syddanmark, Denmark
Praxis fur Pneumologie am DuakoRecruiting
Augsburg, Bavaria, Germany
LMU University Hospital MunichRecruiting
Munich, Bavaria, Germany
IKF Pneumologie Frankfurt GmbH & Co KGRecruiting
Frankfurt am Main, Hesse, Germany
KPPK StudienzentrumRecruiting
Koblenz, Rhineland-Palatinate, Germany
Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)Recruiting
Lübeck, Schleswig-Holstein, Germany
Lungenpraxis Hohenzollerndamm RCMSRecruiting
Berlin, Germany
POIS Sachsen GmbH iGRecruiting
Leipzig, Germany
IKF Pneumologie GmbH & Co. KGRecruiting
Mainz, Germany
Centrum Medyczne All-MedRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Michał Bogacki - DOBROSTANRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Diamond Clinic sp zooRecruiting
Krakow, Malopolska, Poland
European Trial Group (ETG) WarsawRecruiting
Warsaw, Mazovian, Poland
Centrum Medycyny Oddechowej Mroz SJRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Allergy Clinic NZOZ Homeo MedicusRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny NieinwazyjnejRecruiting
Gdansk, Pomeranian Voivodeship, Poland
Lekarze Specjaliści Małolepszy i PartnerzyRecruiting
Wroclaw, Poland
ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut BadawczyRecruiting
Wroclaw, Poland
Allianze pulmonary ResearchRecruiting
Guaynabo, Puerto Rico
Fundacion de Investigacion (FDI) Clinical ResearchRecruiting
San Juan, Puerto Rico
PRCCI Clinical Research CenterRecruiting
San Juan, Puerto Rico
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 · TrialPath