Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-04-22
250
Participants Needed
84
Research Sites
122 weeks
Total Duration
On this page
Sponsors
R
Regeneron Pharmaceuticals
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of asthma for at least 12 months based on GINA 2023 guidance
- Treatment with medium dose ICS/LABA for more than 3 months with stable dose for at least 1 month before visit 1
- Using a maximum of 3 controllers for asthma
- Pre-bronchodilator FEV1 as defined in the protocol
- Reversibility of at least 12% and 200 mL in FEV1 after albuterol/salbutamol at screening or documented history of 20% reduction in FEV1
- Adherence to medium dose ICS/LABA on at least 80% of days during run-in period
- ACQ-5 score of 1.5 or higher at screening (visit 1)
- History of at least 1 severe exacerbation in the previous year but not in the 30 days before visit 1
- Baseline blood eosinophil count of 300 cells/µL or higher at visit 1 (about 90% of population)
You will not qualify if you...
- Diagnosis of COPD or other lung diseases affecting lung function
- Lung disease other than asthma or significant imaging findings within 12 months before and including baseline visit
- Severe asthma exacerbation from 1 month before screening through baseline visit
- Weight under 30 kilograms
- Current smoker or quit smoking within 6 months before visit 1 or smoking history of 10 or more pack-years
- Severe other illnesses that may affect participation
- Use of systemic corticosteroids from 1 month before screening through run-in period
- Other protocol-defined exclusion criteria as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
Kern Research, Inc
Bakersfield, California, United States, 93301
Active, Not Recruiting
2
Modena Allergy & Asthma, Inc.
La Jolla, California, United States, 92037
Active, Not Recruiting
3
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
Active, Not Recruiting
4
Ark Clinical Research, LLC
Long Beach, California, United States, 90815
Active, Not Recruiting
5
Newport Native Md, Inc.
Newport Beach, California, United States, 92663
Active, Not Recruiting
6
Childrens Hospital of Orange County Main Campus
Orange, California, United States, 92868
Actively Recruiting
7
Riviera Allergy Medical Center
Redondo Beach, California, United States, 90277
Withdrawn
8
Raffi Tachdjian MD, Inc.
Santa Monica, California, United States, 90404
Completed
9
Bensch Clinical Research
Stockton, California, United States, 95207
Active, Not Recruiting
10
Integrated Research of Inland, Inc.
Upland, California, United States, 91786
Completed
11
Allianz Research Institute
Westminster, California, United States, 92683
Active, Not Recruiting
12
National Jewish Health
Denver, Colorado, United States, 80206
Active, Not Recruiting
13
St Francis Medical Institute
Clearwater, Florida, United States, 33765
Active, Not Recruiting
14
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Kissimmee, Florida, United States, 34746
Active, Not Recruiting
15
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, United States, 32789
Active, Not Recruiting
16
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Active, Not Recruiting
17
Northwestern University
Chicago, Illinois, United States, 60611
Withdrawn
18
Sneeze Wheeze and Itch Associates
Normal, Illinois, United States, 61761
Active, Not Recruiting
19
Asthma and Allergy Center of Chicago
River Forest, Illinois, United States, 60305
Active, Not Recruiting
20
Endeavor Health, Skokie Campus
Skokie, Illinois, United States, 60077
Active, Not Recruiting
21
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
22
Bluegrass Allergy Research
Lexington, Kentucky, United States, 40509
Active, Not Recruiting
23
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States, 40217
Actively Recruiting
24
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States, 42301
Active, Not Recruiting
25
Paul A. Shapero, M.D.
Bangor, Maine, United States, 04401
Active, Not Recruiting
26
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
27
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Active, Not Recruiting
28
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Active, Not Recruiting
29
Allergy and Asthma Center of Minnesota
Maplewood, Minnesota, United States, 55109
Withdrawn
30
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States, 55402
Active, Not Recruiting
31
Washington University School of Medicine
St Louis, Missouri, United States, 63119
Active, Not Recruiting
32
Montana Medical Research
Missoula, Montana, United States, 59808
Active, Not Recruiting
33
The Asthma and Allergy Center
Bellevue, Nebraska, United States, 68123
Active, Not Recruiting
34
Henderson Clinical Trials
Henderson, Nevada, United States, 89052
Active, Not Recruiting
35
Certified Research Associates
Cortland, New York, United States, 13045
Active, Not Recruiting
36
New York Medical College
Hawthorne, New York, United States, 10532
Actively Recruiting
37
Northwell Health at ENT & Allergy Associates
New York, New York, United States, 10016
Actively Recruiting
38
Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology
Rochester, New York, United States, 14607
Active, Not Recruiting
39
Cincinnati Childrens Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
40
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Active, Not Recruiting
41
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States, 15801
Completed
42
University of Pittsburgh Asthma and Environmental Health Lung Institute
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
43
Pulmonology Associates Inc.
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
44
Dharma MD PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, United States, 75235
Active, Not Recruiting
45
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States, 75020
Active, Not Recruiting
46
Western Sky Medical Research
El Paso, Texas, United States, 79912
Active, Not Recruiting
47
Baylor College of Medicine - Section of Pulmonary and Critical Care
Houston, Texas, United States, 77030
Active, Not Recruiting
48
Texas Children's Hospital
Houston, Texas, United States, 77030
Active, Not Recruiting
49
Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas, United States, 75069
Active, Not Recruiting
50
Lung Sleep Research Institute
North Richland Hills, Texas, United States, 76180
Active, Not Recruiting
51
South Texas Allergy & Asthma Medical Professionals (STAAMP) Research
San Antonio, Texas, United States, 78229
Active, Not Recruiting
52
Allergy & Asthma Care of Waco
Waco, Texas, United States, 76712
Active, Not Recruiting
53
Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray, Utah, United States, 84107
Actively Recruiting
54
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Completed
55
Vancouver Clinic
Vancouver, Washington, United States, 98664
Withdrawn
56
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Active, Not Recruiting
57
Dynamic Drug Advancement Ltd.
Ajax, Ontario, Canada, L1S 2J5
Active, Not Recruiting
58
Evidence Based Medical Educator Inc.
Toronto, Ontario, Canada, M5G 1E2
Active, Not Recruiting
59
Inspiration Research Limited
Toronto, Ontario, Canada, M5T 3A9
Active, Not Recruiting
60
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, Canada, N8X 1T3
Active, Not Recruiting
61
Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval
Québec, Canada, G1V 4G5
Actively Recruiting
62
Clinique de Specialisee en Allergie de la Capitale
Québec, Canada, G1V 4W2
Active, Not Recruiting
63
Copenhagen University Hospital - Hvidovre
Hvidovre, Capital Region, Denmark, 2650
Withdrawn
64
Vejle Sygehus
Vejle, Region Syddanmark, Denmark, 7100
Active, Not Recruiting
65
Praxis fur Pneumologie am Duako
Augsburg, Bavaria, Germany, 86150
Actively Recruiting
66
LMU University Hospital Munich
Munich, Bavaria, Germany, 81377
Active, Not Recruiting
67
IKF Pneumologie Frankfurt GmbH & Co KG
Frankfurt am Main, Hesse, Germany, 60596
Active, Not Recruiting
68
KPPK Studienzentrum
Koblenz, Rhineland-Palatinate, Germany, 56068
Active, Not Recruiting
69
Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)
Lübeck, Schleswig-Holstein, Germany, 23552
Active, Not Recruiting
70
Lungenpraxis Hohenzollerndamm RCMS
Berlin, Germany, 10717
Active, Not Recruiting
71
POIS Sachsen GmbH iG
Leipzig, Germany, 04347
Active, Not Recruiting
72
IKF Pneumologie GmbH & Co. KG
Mainz, Germany, 55128
Active, Not Recruiting
73
Centrum Medyczne All-Med
Krakow, Lesser Poland Voivodeship, Poland, 30-033
Active, Not Recruiting
74
Michał Bogacki - DOBROSTAN
Wroclaw, Lower Silesian Voivodeship, Poland, 53301
Active, Not Recruiting
75
Diamond Clinic sp zoo
Krakow, Malopolska, Poland, 31-559
Active, Not Recruiting
76
European Trial Group (ETG) Warsaw
Warsaw, Mazovian, Poland, 02-677
Actively Recruiting
77
Centrum Medycyny Oddechowej Mroz SJ
Bialystok, Podlaskie Voivodeship, Poland, 15-044
Active, Not Recruiting
78
Allergy Clinic NZOZ Homeo Medicus
Bialystok, Podlaskie Voivodeship, Poland, 15-687
Active, Not Recruiting
79
Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Active, Not Recruiting
80
Lekarze Specjaliści Małolepszy i Partnerzy
Wroclaw, Poland, 54239
Active, Not Recruiting
81
ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy
Wroclaw, Poland, PL-53-201
Active, Not Recruiting
82
Allianze pulmonary Research
Guaynabo, Puerto Rico, 00968
Withdrawn
83
Fundacion de Investigacion (FDI) Clinical Research
San Juan, Puerto Rico, 00927
Withdrawn
84
PRCCI Clinical Research Center
San Juan, Puerto Rico, 00927
Active, Not Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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