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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06572228
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    Administered by subcutaneous (SC) injection
  • Matching Placebo — DRUG
    Administered by SC injection
  • ICS/LABA — DRUG
    Administered at a blinded dose

Study Details

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

Key Dates

Start date
Aug 26, 2024
Status verified
Apr 2026
Primary completion
Apr 24, 2027
Completion
Apr 24, 2027

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab + ICS/LABA
    Randomized 1:1
  • Placebo Comparator: Placebo + ICS/LABA
    Randomized 1:1

Primary Outcome Measure

Annualized severe asthma exacerbation rate [ Time Frame: Baseline through Week 52 ]

Locations (51)

FacilityCityStateZIPSite coordinators
Kern Research, IncBakersfieldCalifornia93301-
Modena Allergy & Asthma, Inc.La JollaCalifornia92037-
Antelope Valley Clinical TrialsLancasterCalifornia93534-
Ark Clinical Research, LLCLong BeachCalifornia90815-
Newport Native Md, Inc.Newport BeachCalifornia92663-
Childrens Hospital of Orange County Main CampusOrangeCalifornia92868-
Raffi Tachdjian MD, Inc.Santa MonicaCalifornia90404-
Bensch Clinical ResearchStocktonCalifornia95207-
Integrated Research of Inland, Inc.UplandCalifornia91786-
Allianz Research InstituteWestminsterCalifornia92683-
National Jewish HealthDenverColorado80206-
St Francis Medical InstituteClearwaterFlorida33765-
Florida Lung, Asthma and Sleep Specialists (FLASS) - CelebrationKissimmeeFlorida34746-
Clinical Site Partners, LLC DBA Flourish ResearchWinter ParkFlorida32789-
Treasure Valley Medical ResearchBoiseIdaho83706-
Sneeze Wheeze and Itch AssociatesNormalIllinois61761-
Asthma and Allergy Center of ChicagoRiver ForestIllinois60305-
Endeavor Health, Skokie CampusSkokieIllinois60077-
University of Kansas Medical CenterKansas CityKansas66160-
Bluegrass Allergy ResearchLexingtonKentucky40509-
Family Allergy and Asthma Research InstituteLouisvilleKentucky40217-
Allergy & Asthma Specialists, P.S.C.OwensboroKentucky42301-
Paul A. Shapero, M.D.BangorMaine04401-
Massachusetts General HospitalBostonMassachusetts02114-
Michigan MedicineAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Clinical Research Institute, Inc.MinneapolisMinnesota55402-
Washington University School of MedicineSt LouisMissouri63119-
Montana Medical ResearchMissoulaMontana59808-
The Asthma and Allergy CenterBellevueNebraska68123-
Henderson Clinical TrialsHendersonNevada89052-
Certified Research AssociatesCortlandNew York13045-
New York Medical CollegeHawthorneNew York10532-
Northwell Health at ENT & Allergy AssociatesNew YorkNew York10016-
Rochester Regional Health - Alexander Park - Allergy, Immunology & RheumatologyRochesterNew York14607-
Cincinnati Childrens Hospital and Medical CenterCincinnatiOhio45229-
Allergy Asthma and Clinical Research CenterOklahoma CityOklahoma73120-
Clinical Research Associates of Central PADuBoisPennsylvania15801-
University of Pittsburgh Asthma and Environmental Health Lung InstitutePittsburghPennsylvania15213-
Pulmonology Associates Inc.WynnewoodPennsylvania19096-
Dharma MD PA d/b/a Southwest Family Medicine AssociatesDallasTexas75235-
Premier Pulmonary Critical Care and Sleep MedicineDenisonTexas75020-
Western Sky Medical ResearchEl PasoTexas79912-
Baylor College of Medicine - Section of Pulmonary and Critical CareHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-
Metroplex Pulmonary and Sleep Center, PAMcKinneyTexas75069-
Lung Sleep Research InstituteNorth Richland HillsTexas76180-
South Texas Allergy & Asthma Medical Professionals (STAAMP) ResearchSan AntonioTexas78229-
Allergy & Asthma Care of WacoWacoTexas76712-
Intermountain Medical Center - Murray (Pulmonary Medicine)MurrayUtah84107-
Inova Fairfax HospitalFalls ChurchVirginia22042-

Find similar trials in Bakersfield, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Kern Research, Inc· Bakersfield, CAModena Allergy & Asthma, Inc.· La Jolla, CAAntelope Valley Clinical Trials· Lancaster, CAArk Clinical Research, LLC· Long Beach, CANewport Native Md, Inc.· Newport Beach, CAChildrens Hospital of Orange County Main Campus· Orange, CA

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