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Clinical Trials in the USA / NCT06572228
Active, not recruiting Phase 4

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 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 4
Started
2024-08-26
Last updated
2026-05-22

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

dupilumabMatching PlaceboICS/LABA

dupilumab: Administered by subcutaneous (SC) injection

Matching Placebo: Administered by SC injection

ICS/LABA: Administered at a blinded dose

Study 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

Sex
ALL
Min age
12 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
Kern Research, Inc Bakersfield California
Modena Allergy & Asthma, Inc. La Jolla California
Antelope Valley Clinical Trials Lancaster California
Ark Clinical Research, LLC Long Beach California
Newport Native Md, Inc. Newport Beach California
Childrens Hospital of Orange County Main Campus Orange California
Raffi Tachdjian MD, Inc. Santa Monica California
Bensch Clinical Research Stockton California
Integrated Research of Inland, Inc. Upland California
Allianz Research Institute Westminster California
National Jewish Health Denver Colorado
St Francis Medical Institute Clearwater Florida
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration Kissimmee Florida
Clinical Site Partners, LLC DBA Flourish Research Winter Park Florida
Treasure Valley Medical Research Boise Idaho
Sneeze Wheeze and Itch Associates Normal Illinois
Asthma and Allergy Center of Chicago River Forest Illinois
Endeavor Health, Skokie Campus Skokie Illinois
University of Kansas Medical Center Kansas City Kansas
Bluegrass Allergy Research Lexington Kentucky
Family Allergy and Asthma Research Institute Louisville Kentucky
Allergy & Asthma Specialists, P.S.C. Owensboro Kentucky
Paul A. Shapero, M.D. Bangor Maine
Massachusetts General Hospital Boston Massachusetts
Michigan Medicine Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
Clinical Research Institute, Inc. Minneapolis Minnesota
Washington University School of Medicine St Louis Missouri
Montana Medical Research Missoula Montana
The Asthma and Allergy Center Bellevue Nebraska
Henderson Clinical Trials Henderson Nevada
Certified Research Associates Cortland New York
New York Medical College Hawthorne New York
Northwell Health at ENT & Allergy Associates New York New York
Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology Rochester New York
Cincinnati Childrens Hospital and Medical Center Cincinnati Ohio
Allergy Asthma and Clinical Research Center Oklahoma City Oklahoma
Clinical Research Associates of Central PA DuBois Pennsylvania
University of Pittsburgh Asthma and Environmental Health Lung Institute Pittsburgh Pennsylvania
Pulmonology Associates Inc. Wynnewood Pennsylvania

+ 37 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06572228 on ClinicalTrials.gov ↗ ← All trials in the USA