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
- Registration Number
- NCT06572228
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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
- Detailed Description
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
- 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
- Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
- Pre-bronchodilator FEV1, as defined in the protocol
- 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
- Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
- ACQ-5 score ≥1.5 at screening (visit 1)
- History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
- Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol
Key
- Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
- 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)
- 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
- Weight is less than 30 kilograms
- Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab + ICS/LABA dupilumab Randomized 1:1 Dupilumab + ICS/LABA ICS/LABA Randomized 1:1 Placebo + ICS/LABA Matching Placebo Randomized 1:1 Placebo + ICS/LABA ICS/LABA Randomized 1:1
- Primary Outcome Measures
Name Time Method Annualized severe asthma exacerbation rate Baseline through Week 52
- Secondary Outcome Measures
Name Time Method Change in FEV1: FVC ratio Baseline up to week 52 Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations Baseline to week 52 Proportion of participants achieving ACQ-5 <1.5 At week 12 Change in pre-bronchodilator FEV1 Baseline up to week 52 Change in percent predicted FEV1 Baseline up to week 52 Change in forced expiratory flow (FEF) 25-75% Baseline up to week 52 Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5 Up to week 52 Incidence of Treatment-emergent adverse event (TEAEs) Up to week 52 Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1) Baseline to week 12 Change in peak expiratory flow (PEF) Baseline up to week 52 Change in post-bronchodilator FEV1 Baseline up to week 52 Time to first severe exacerbation event Up to week 52 Change in Asthma Control Questionnaire (ACQ-5) Baseline to week 12 The ACQ-5 has 5 items that assess the most common asthma symptoms: 1. Frequency in past week awoken by asthma during the night, 2. Severity of asthma symptoms in the morning, 3. Limitation of daily activities due to asthma, 4. Shortness of breath due to asthma and 5. Wheeze. Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The ACQ-5 global score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.
Change in forced vital capacity (FVC) Baseline up to week 52
Trial Locations
- Locations (77)
Allergy Clinic NZOZ Homeo Medicus
🇵🇱Bialystok, Poland
Fundacion de Investigacion (FDI) Clinical Research
🇵🇷San Juan, Puerto Rico
Lekarze Specjaliści Małolepszy i Partnerzy
🇵🇱Wroclaw, Poland
ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy
🇵🇱Wroclaw, Poland
Lungenpraxis Hohenzollerndamm RCMS
🇩🇪Berlin, Germany
POIS Sachsen GmbH iG
🇩🇪Leipzig, Germany
IKF Pneumologie GmbH & Co. KG
🇩🇪Mainz, Germany
Allianze pulmonary Research
🇵🇷Guaynabo, Puerto Rico
Kern Research, Inc
🇺🇸Bakersfield, California, United States
Modena Allergy & Asthma, Inc.
🇺🇸La Jolla, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Ark Clinical Research - Long Beach
🇺🇸Long Beach, California, United States
Newport Native Md, Inc.
🇺🇸Newport Beach, California, United States
Riviera Allergy Medical Center
🇺🇸Redondo Beach, California, United States
Raffi Tachdjian MD inc
🇺🇸Santa Monica, California, United States
Bensch Clinical Research
🇺🇸Stockton, California, United States
Integrated Research of Inland, Inc.
🇺🇸Upland, California, United States
Allianz Research Institute
🇺🇸Westminster, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
St Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
🇺🇸Kissimmee, Florida, United States
Clinical Site Partners, LLC DBA Flourish Research
🇺🇸Winter Park, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Sneeze Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
Asthma and Allergy Center of Chicago
🇺🇸River Forest, Illinois, United States
NorthShore University Health System
🇺🇸Skokie, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Bluegrass Allergy Research
🇺🇸Lexington, Kentucky, United States
Family Allergy and Asthma Research Institute
🇺🇸Louisville, Kentucky, United States
Allergy & Asthma Specialists, P.S.C.
🇺🇸Owensboro, Kentucky, United States
Paul A. Shapero, M.D.
🇺🇸Bangor, Maine, United States
Massachusetts General Hospital
🇺🇸Dover, Massachusetts, United States
Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Allergy and Asthma Center of Minnesota
🇺🇸Maplewood, Minnesota, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
The Asthma and Allergy Center
🇺🇸Bellevue, Nebraska, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Certified Research Associates
🇺🇸Cortland, New York, United States
New York Medical College
🇺🇸Hawthorne, New York, United States
Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology
🇺🇸Rochester, New York, United States
Cincinnati Childrens Hospital and Medical Center
🇺🇸Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Associates of Central PA
🇺🇸DuBois, Pennsylvania, United States
Pulmonology Associates Inc.
🇺🇸Wynnewood, Pennsylvania, United States
Dharma MD PA doing business as Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
🇺🇸Denison, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
PRCCI Clinical Research Center
🇵🇷San Juan, Puerto Rico
Baylor College of Medicine - Section of Pulmonary and Critical Care
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Metroplex Pulmonary and Sleep Center, PA
🇺🇸McKinney, Texas, United States
Lung Sleep Research Institute
🇺🇸North Richland Hills, Texas, United States
South Texas Allegry & Asthma Medical Professionals (STAAMP) Research
🇺🇸San Antonio, Texas, United States
Allergy & Asthma Care of Waco
🇺🇸Waco, Texas, United States
Vancouver Clinic
🇺🇸Vancouver, Washington, United States
The Lung Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Dynamic Drug Advancement Ltd.
🇨🇦Ajax, Ontario, Canada
Evidence Based Medical Educator Inc.
🇨🇦Toronto, Ontario, Canada
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
Dr. Syed Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Clinique de Specialisee en Allergie de la Capitale
🇨🇦Quebec, Canada
Vejle Sygehus
🇩🇰Vejle, South Denmark, Denmark
Copenhagen University Hospital - Hvidovre
🇩🇰Hvidovre, Denmark
Lmu University Hospital
🇩🇪Munich, Bavaria, Germany
Praxis fur Pneumologie am Duako
🇩🇪Augsburg, Bayern, Germany
IKF Pneumologie Frankfurt GmbH & Co KG
🇩🇪Frankfurt, Hessen, Germany
KPPK Studienzentrum
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)
🇩🇪Lubeck, Schleswig-Holstein, Germany
Michał Bogacki - DOBROSTAN
🇵🇱Wroclaw, Dolnoslaskie, Poland
Diamond Clinic sp zoo
🇵🇱Krakow, Malopolska, Poland
Centrum Medyczne All-Med
🇵🇱Kraków, Malopolskie, Poland
Centrum Medycyny Oddechowej Mroz SJ
🇵🇱Białystok, Podlaskie, Poland
Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej
🇵🇱Gdansk, Pomerania, Poland