Actively Recruiting
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Led by Sanofi · Updated on 2026-03-20
90
Participants Needed
74
Research Sites
259 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
CONDITIONS
Official 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...
- Participant must be 2 to <6 years of age
- Diagnosis of asthma or recurrent severe asthmatic wheeze not controlled with chronic inhaled corticosteroids for at least 3 months
- Stable use of at least low dose inhaled corticosteroids for at least 1 month prior to screening
- At least one major criterion from the modified asthma predictive index: physician-diagnosed atopic dermatitis or allergic sensitization to at least one aeroallergen (serum IgE ≥0.35 kU/L)
- OR two minor criteria: wheezing unrelated to colds, peripheral blood eosinophilia ≥4%, or allergic sensitization to milk, eggs, or peanuts (serum specific IgE >0.35 kU/L)
- Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study procedures
- Parent(s)/caregiver(s)/legal guardian(s) able to understand study requirements
- Participants or their parent(s)/caregiver(s)/legal guardian(s) able to understand and complete study questionnaires
- Body weight at screening and randomization >5 kg and <30 kg
- Parent(s)/caregiver(s)/legal guardian(s) capable of giving signed informed consent
You will not qualify if you...
- Severe asthma requiring chronic oral or systemic corticosteroid use for more than 1 month continuous at screening
- History of systemic hypersensitivity reaction or anaphylaxis to biologic therapy or any excipient
- History of prematurity (less than 34 weeks gestation)
- Any chronic lung disease impairing lung function (e.g., cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or oxygen need for more than 5 days in the neonatal period
- History of life-threatening asthma requiring intubation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
CONTACT
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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