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Purpose

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

Condition

Eligibility

Eligible Ages
Between 12 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dupilumab + ICS/LABA 		Randomized 1:1
  • Drug: dupilumab
    Administered by subcutaneous (SC) injection
    Other names:
    • Dupixent®
    • REGN668
    • SAR231893
  • Drug: ICS/LABA
    Administered at a blinded dose
    Other names:
    • fluticasone
    • propionate/salmeterol HFA
    • inhalation aerosol
Placebo Comparator
Placebo + ICS/LABA 		Randomized 1:1
  • Drug: Matching Placebo
    Administered by SC injection
  • Drug: ICS/LABA
    Administered at a blinded dose
    Other names:
    • fluticasone
    • propionate/salmeterol HFA
    • inhalation aerosol

Recruiting Locations

Kern Research, Inc
Bakersfield, California 93301

Modena Allergy & Asthma, Inc.
La Jolla, California 92037

Antelope Valley Clinical Trials
Lancaster, California 93534

Ark Clinical Research - Long Beach
Long Beach, California 90815

Newport Native Md, Inc.
Newport Beach, California 92663

Riviera Allergy Medical Center
Redondo Beach, California 90277

Raffi Tachdjian MD inc
Santa Monica, California 90404

Bensch Clinical Research
Stockton, California 95207

Integrated Research of Inland, Inc.
Upland, California 91786

Allianz Research Institute
Westminster, California 92683

National Jewish Health
Denver, Colorado 80206

St Francis Medical Institute
Clearwater, Florida 33765

Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Kissimmee, Florida 34746

Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida 32789

Treasure Valley Medical Research
Boise, Idaho 83706

Northwestern University
Chicago, Illinois 60611

Sneeze Wheeze and Itch Associates
Normal, Illinois 61761

Asthma and Allergy Center of Chicago
River Forest, Illinois 60305

NorthShore University Health System
Skokie, Illinois 60077

University of Kansas Medical Center
Kansas City, Kansas 66160

Bluegrass Allergy Research
Lexington, Kentucky 40509

Family Allergy and Asthma Research Institute
Louisville, Kentucky 40217

Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky 42301

Paul A. Shapero, M.D.
Bangor, Maine 04401

Massachusetts General Hospital
Dover, Massachusetts 02114

Michigan Medicine
Ann Arbor, Michigan 48109

Henry Ford Health System
Detroit, Michigan 48202

Allergy and Asthma Center of Minnesota
Maplewood, Minnesota 55109

Clinical Research Institute, Inc.
Minneapolis, Minnesota 55402

Washington University School of Medicine
Saint Louis, Missouri 63119

Montana Medical Research
Missoula, Montana 59808

The Asthma and Allergy Center
Bellevue, Nebraska 68123

Henderson Clinical Trials
Henderson, Nevada 89052

Certified Research Associates
Cortland, New York 13045

New York Medical College
Hawthorne, New York 10592

Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology
Rochester, New York 14607

Cincinnati Childrens Hospital and Medical Center
Cincinnati, Ohio 45229

Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma 73120

Clinical Research Associates of Central PA
DuBois, Pennsylvania 15801

Pulmonology Associates Inc.
Wynnewood, Pennsylvania 19096

Dharma MD PA doing business as Southwest Family Medicine Associates
Dallas, Texas 75235

Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas 75020

Western Sky Medical Research
El Paso, Texas 79912

Baylor College of Medicine - Section of Pulmonary and Critical Care
Houston, Texas 77030

Texas Children's Hospital
Houston, Texas 77030

Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas 75069

Lung Sleep Research Institute
North Richland Hills, Texas 76180

South Texas Allegry & Asthma Medical Professionals (STAAMP) Research
San Antonio, Texas 78229

Allergy & Asthma Care of Waco
Waco, Texas 76712

Vancouver Clinic
Vancouver, Washington 98664

Allianze pulmonary Research
Guaynabo, Puerto Rico 00968

Fundacion de Investigacion (FDI) Clinical Research
San Juan, Puerto Rico 00927

PRCCI Clinical Research Center
San Juan, Puerto Rico 00927

More Details

NCT ID
NCT06572228
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Detailed Description

This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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