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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 Sex
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 5325738, California 5332921 93301

Modena Allergy & Asthma, Inc.
La Jolla 5363943, California 5332921 92037

Antelope Valley Clinical Trials
Lancaster 5364940, California 5332921 93534

Ark Clinical Research - Long Beach
Long Beach 5367929, California 5332921 90815

Newport Native Md, Inc.
Newport Beach 5376890, California 5332921 92663

Childrens Hospital of Orange County Main Campus
Orange 5379513, California 5332921 92868

Riviera Allergy Medical Center
Redondo Beach 5386785, California 5332921 90277

Raffi Tachdjian MD, Inc.
Santa Monica 5393212, California 5332921 90404

Bensch Clinical Research
Stockton 5399020, California 5332921 95207

Integrated Research of Inland, Inc.
Upland 5404915, California 5332921 91786

Allianz Research Institute
Westminster 5408406, California 5332921 92683

National Jewish Health
Denver 5419384, Colorado 5417618 80206

St Francis Medical Institute
Clearwater 4151316, Florida 4155751 33765

Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Kissimmee 4160983, Florida 4155751 34746

Clinical Site Partners, LLC DBA Flourish Research
Winter Park 4178560, Florida 4155751 32789

Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706

Northwestern University
Chicago 4887398, Illinois 4896861 60611

Sneeze Wheeze and Itch Associates
Normal 4903780, Illinois 4896861 61761

Asthma and Allergy Center of Chicago
River Forest 4907637, Illinois 4896861 60305

NorthShore University Health System
Skokie 4911600, Illinois 4896861 60077

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160

Bluegrass Allergy Research
Lexington 4297983, Kentucky 6254925 40509

Family Allergy and Asthma Research Institute
Louisville 4299276, Kentucky 6254925 40217

Allergy & Asthma Specialists, P.S.C.
Owensboro 4303436, Kentucky 6254925 42301

Paul A. Shapero, M.D.
Bangor 4957280, Maine 4971068 04401

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Michigan Medicine
Ann Arbor 4984247, Michigan 5001836 48109

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Allergy and Asthma Center of Minnesota
Maplewood 5036588, Minnesota 5037779 55109

Clinical Research Institute, Inc.
Minneapolis 5037649, Minnesota 5037779 55402

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63119

Montana Medical Research
Missoula 5666639, Montana 5667009 59808

The Asthma and Allergy Center
Bellevue 5063805, Nebraska 5073708 68123

Henderson Clinical Trials
Henderson 5505411, Nevada 5509151 89052

Certified Research Associates
Cortland 5113790, New York 5128638 13045

New York Medical College
Hawthorne 5120284, New York 5128638 10532

Northwell Health at ENT & Allergy Associates
New York 5128581, New York 5128638 10016

Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology
Rochester 5134086, New York 5128638 14607

Cincinnati Childrens Hospital and Medical Center
Cincinnati 4508722, Ohio 5165418 45229

Allergy Asthma and Clinical Research Center
Oklahoma City 4544349, Oklahoma 4544379 73120

Clinical Research Associates of Central PA
DuBois 5187432, Pennsylvania 6254927 15801

University of Pittsburgh Asthma and Environmental Health Lung Institute
Pittsburgh 5206379, Pennsylvania 6254927 15213

Pulmonology Associates Inc.
Wynnewood 5220230, Pennsylvania 6254927 19096

Dharma MD PA d/b/a Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286 75235

Premier Pulmonary Critical Care and Sleep Medicine
Denison 4685892, Texas 4736286 75020

Western Sky Medical Research
El Paso 5520993, Texas 4736286 79912

Baylor College of Medicine - Section of Pulmonary and Critical Care
Houston 4699066, Texas 4736286 77030

Texas Children's Hospital
Houston 4699066, Texas 4736286 77030

Metroplex Pulmonary and Sleep Center, PA
McKinney 4710178, Texas 4736286 75069

Lung Sleep Research Institute
North Richland Hills 4715292, Texas 4736286 76180

South Texas Allergy & Asthma Medical Professionals (STAAMP) Research
San Antonio 4726206, Texas 4736286 78229

Allergy & Asthma Care of Waco
Waco 4739526, Texas 4736286 76712

Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray 5778755, Utah 5549030 84107

Inova Fairfax Hospital
Falls Church 4758390, Virginia 6254928 22042

Allianze pulmonary Research
Guaynabo 4565119, Puerto Rico 00968

Fundacion de Investigacion (FDI) Clinical Research
San Juan 4568127, Puerto Rico 00927

PRCCI Clinical Research Center
San Juan 4568127, Puerto Rico 00927

More Details

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.