Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Long-term Safety of Dupilumab in Children 2 to <6 Years With Uncontrolled Asthma and Recurrent Severe Asthmatic Wheeze
Led by Sanofi · Updated on 2026-03-20
90
Participants Needed
74
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dupilumab treatment on children aged 2 to under 6 years with uncontrolled asthma and/or recurrent severe asthmatic wheeze. This Phase 3 study aims to assess both the efficacy and long-term safety of dupilumab compared to a placebo. The study is conducted in two parts to thoroughly evaluate treatment outcomes and safety over an extended period. In Part A, children will be randomly assigned to receive either dupilumab or a matching placebo through subcutaneous injections over a 52-week treatment period following a 4-week screening phase. After this, there is a 12-week follow-up to monitor any ongoing effects. Participants who qualify may choose to enter Part B, an optional open-label extension where all receive dupilumab for an additional 52 weeks, followed by another 12-week safety follow-up. Throughout the study, participants will be regularly assessed for asthma exacerbations, medication use, symptom control, quality of life, and medication safety. Caregivers will complete diaries and questionnaires about asthma symptoms and control. Blood tests will monitor eosinophil levels, immune responses, and drug concentrations. The total time in the study can be up to 120 weeks, allowing researchers to observe long-term treatment effects and safety.
CONDITIONS
Brief Title
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 2 to under 6 years
- Diagnosis of asthma or recurrent severe asthmatic wheeze not controlled with inhaled corticosteroids for at least 3 months
- Stable use of at least low dose inhaled corticosteroids for 1 month prior to screening
- Evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze
- At least one major criterion from modified asthma predictive index: physician diagnosed atopic dermatitis or allergic sensitization to at least one aeroallergen
- Or two minor criteria: wheezing unrelated to colds, peripheral blood eosinophilia ≥4%, or allergic sensitization to milk, eggs, or peanuts
- Parent(s)/caregiver(s) willing and able to comply with study visits and procedures
- Ability to understand and complete study questionnaires
- Body weight between 5 kg and 30 kg at screening and randomization
- Signed informed consent by parent(s), caregiver(s), or legal guardian(s)
You will not qualify if you...
- Need for chronic oral/systemic corticosteroid use for more than 1 month at screening
- History of systemic hypersensitivity reaction or anaphylaxis to biologic therapy
- History of prematurity before 34 weeks gestation
- Other chronic lung diseases affecting lung function (e.g., cystic fibrosis, bronchopulmonary dysplasia)
- Chronic lung disease of prematurity or need for oxygen more than 5 days in neonatal period
- History of life-threatening asthma requiring intubation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive subcutaneous injections of Dupilumab or placebo as per protocol to evaluate efficacy and safety in controlling asthma symptoms.
Regular visits during the 52-week treatment period
Duration - Up to 64 weeks
Participants are monitored for safety and adverse events after the initial treatment period.
Visits from Week 52 through Week 116
Trial Site Locations
Total: 74 locations
1
Phoenix Children's Hospital- Site Number : 8400001
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Allervie Clinical Research - Destin- Site Number : 8400016
Destin, Florida, United States, 32541
Actively Recruiting
3
EMDA Clinical Research- Site Number : 8400026
Miami, Florida, United States, 33126
Actively Recruiting
4
Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Allergy and Asthma Specialist- Site Number : 8400002
Owensboro, Kentucky, United States, 42301
Actively Recruiting
6
Mayo Clinic in Rochester - Minnesota- Site Number : 8400008
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
UBMD Pediatrics- Site Number : 8400013
Buffalo, New York, United States, 14203
Actively Recruiting
8
Boston Children's Health Physicians - Hawthorne- Site Number : 8400010
Hawthorne, New York, United States, 10532
Actively Recruiting
9
UNC Children's Hospital- Site Number : 8400005
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Cincinnati Children's Hospital Medical Center- Site Number : 8400004
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
University Hospitals Cleveland Medical Center- Site Number : 8400015
Cleveland, Ohio, United States, 44106
Actively Recruiting
12
Vanderbilt University Medical Center- Site Number : 8400024
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
South Texas Medical Research Institute - TTS Research- Site Number : 8400022
Boerne, Texas, United States, 78006
Actively Recruiting
14
Texas Children's Hospital- Site Number : 8400027
Houston, Texas, United States, 77030
Actively Recruiting
15
Investigational Site Number : 0320005
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
16
Investigational Site Number : 0320008
Buenos Aires, Argentina, 1028
Actively Recruiting
17
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1121
Actively Recruiting
18
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1122
Actively Recruiting
19
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1414
Actively Recruiting
20
Investigational Site Number : 0320009
Corrientes, Argentina, 3400
Actively Recruiting
21
Investigational Site Number : 0320006
Córdoba, Argentina, 5003
Actively Recruiting
22
Investigational Site Number : 0320004
Mendoza, Argentina, 5500
Actively Recruiting
23
Hospital Ernesto Dornelles- Site Number : 0760004
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
Active, Not Recruiting
24
Clinica de Alergia Martti Antila- Site Number : 0760002
Sorocaba, São Paulo, Brazil, 18040-425
Active, Not Recruiting
25
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo, Brazil, 05403-000
Active, Not Recruiting
26
Investigational Site Number : 1240002
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
27
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
28
Investigational Site Number : 1240008
Burlington, Ontario, Canada, L7L 6W6
Actively Recruiting
29
Investigational Site Number : 1240007
Hamilton, Ontario, Canada, L8S 1G5
Actively Recruiting
30
Investigational Site Number : 1240006
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
31
Investigational Site Number : 1240005
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
32
Investigational Site Number : 2030001
Prague, Czechia, 190 00
Actively Recruiting
33
Investigational Site Number : 2500005
Créteil, France, 94010
Actively Recruiting
34
Investigational Site Number : 2500001
Lille, France, 59000
Actively Recruiting
35
Investigational Site Number : 2500004
Nice, France, 06200
Actively Recruiting
36
Investigational Site Number : 2500002
Paris, France, 75019
Actively Recruiting
37
Investigational Site Number : 2500003
Paris, France, 75571
Actively Recruiting
38
Investigational Site Number : 2760002
Düsseldorf, Germany, 40217
Actively Recruiting
39
Investigational Site Number : 2760004
Frankfurt, Germany, 60590
Actively Recruiting
40
Investigational Site Number : 2760001
Leipzig, Germany, 04103
Actively Recruiting
41
Investigational Site Number : 3000001
Athens, Greece, 115 27
Actively Recruiting
42
Investigational Site Number : 3000003
Athens, Greece, 152 36
Actively Recruiting
43
Investigational Site Number : 3480005
Budapest, Hungary, 1085
Actively Recruiting
44
Investigational Site Number : 3480004
Debrecen, Hungary, 4032
Actively Recruiting
45
Investigational Site Number : 3480002
Székesfehérvár, Hungary, 8000
Actively Recruiting
46
Investigational Site Number : 3480001
Szigetvár, Hungary, 7900
Actively Recruiting
47
Buzzi Children's Hospital - Investigational Site Number : 3800003
Milan, Lombardy, Italy, 20154
Actively Recruiting
48
Investigational Site Number : 3800005
Padua, Padova, Italy, 35128
Actively Recruiting
49
Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002
Rome, Roma, Italy, 00165
Actively Recruiting
50
AOU Luigi Vanvitelli - Investigational Site Number : 3800004
Naples, Italy, 80131
Actively Recruiting
51
Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001
Pavia, Italy, 27100
Actively Recruiting
52
Investigational Site Number : 3920006
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
53
Investigational Site Number : 3920004
Tsu, Mie-ken, Japan, 514-0125
Actively Recruiting
54
Investigational Site Number : 3920003
Ureshino, Saga-ken, Japan, 843-0393
Actively Recruiting
55
Investigational Site Number : 3920002
Fukuoka, Japan, 811-1394
Actively Recruiting
56
Investigational Site Number : 3920001
Fukuoka, Japan, 813-0017
Actively Recruiting
57
Investigational Site Number : 4840001
San Juan del Río, Querétaro, Mexico, 76800
Actively Recruiting
58
Investigational Site Number : 4840004
Durango, Mexico, 34000
Actively Recruiting
59
Investigational Site Number : 4840002
Veracruz, Mexico, 91900
Actively Recruiting
60
Investigational Site Number : 5280001
Rotterdam, Netherlands, 3015 CE
Completed
61
Investigational Site Number : 6160004
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Actively Recruiting
62
Investigational Site Number : 6160001
Lodz, Lódzkie, Poland, 93-509
Actively Recruiting
63
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, Poland, 02-091
Actively Recruiting
64
Investigational Site Number : 7240003
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
Actively Recruiting
65
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
66
Investigational Site Number : 7240007
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
67
Investigational Site Number : 7240002
Sabadell, Barcelona [Barcelona], Spain, 08208
Actively Recruiting
68
Investigational Site Number : 7240006
Jerez de la Frontera, Cádiz, Spain, 11407
Actively Recruiting
69
Investigational Site Number : 7240005
Madrid, Spain, 28009
Actively Recruiting
70
Investigational Site Number : 7240004
Valencia, Spain, 46026
Actively Recruiting
71
Investigational Site Number : 8260003
Birmingham, England, United Kingdom, B4 6NH
Actively Recruiting
72
Investigational Site Number : 8260002
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
73
Investigational Site Number : 8260001
London, London, City of, United Kingdom, SE5 9RL
Actively Recruiting
74
Investigational Site Number : 8260004
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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