Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
NCT ID: NCT06191315
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2024-01-03
2028-12-21
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dupilumab (double-blind period)
Dupilumab subcutaneous injection as per protocol
Dupilumab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Placebo
Placebo matching dupilumab subcutaneous injection as per protocol
Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Interventions
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Dupilumab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze.
* At least one additional major criterion from the modified asthma predictive index:
1. Physician diagnosed Atopic Dermatitis,
2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
OR 2 minor criteria:
3. Wheezing unrelated to colds,
4. Peripheral blood eosinophilia ≥4%,
5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE \>0.35 kU/L.
* Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
* Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
* Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires
* Body weight at screening and randomization \>5 kg and \<30 kg.
* Parents or caregivers or legal guardian capable of giving signed informed consent.
Exclusion Criteria
* Severe asthma with the need for chronic oral/systemic corticosteroid use (\>1 month continuous) at the time of screening enrollment.
* History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.
* History of prematurity (\<34 weeks gestation).
* Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
* History of life-threatening asthma (eg, requiring intubation).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
2 Years
5 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital- Site Number : 8400001
Phoenix, Arizona, United States
Allervie Clinical Research - Destin- Site Number : 8400016
Destin, Florida, United States
EMDA Clinical Research- Site Number : 8400026
Miami, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011
Chicago, Illinois, United States
Allergy and Asthma Specialist- Site Number : 8400002
Owensboro, Kentucky, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400008
Rochester, Minnesota, United States
UBMD Pediatrics- Site Number : 8400013
Buffalo, New York, United States
Boston Children's Health Physicians - Hawthorne- Site Number : 8400010
Hawthorne, New York, United States
UNC Children's Hospital- Site Number : 8400005
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400004
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center- Site Number : 8400015
Cleveland, Ohio, United States
Vanderbilt University Medical Center- Site Number : 8400024
Nashville, Tennessee, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400022
Boerne, Texas, United States
Texas Children's Hospital - Baylor - PIN- Site Number : 8400027
Houston, Texas, United States
Investigational Site Number : 0320005
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Corrientes, , Argentina
Investigational Site Number : 0320006
Córdoba, , Argentina
Investigational Site Number : 0320004
Mendoza, , Argentina
Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760006
Recife, Pernambuco, Brazil
Hospital Ernesto Dornelles- Site Number : 0760004
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760002
Sorocaba, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo, , Brazil
Investigational Site Number : 1240002
Edmonton, Alberta, Canada
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada
Investigational Site Number : 1240008
Burlington, Ontario, Canada
Investigational Site Number : 1240007
Hamilton, Ontario, Canada
Investigational Site Number : 1240006
Montreal, Quebec, Canada
Investigational Site Number : 1240005
Sherbrooke, Quebec, Canada
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2500005
Créteil, , France
Investigational Site Number : 2500001
Lille, , France
Investigational Site Number : 2500004
Nice, , France
Investigational Site Number : 2500002
Paris, , France
Investigational Site Number : 2500003
Paris, , France
Investigational Site Number : 2760002
Düsseldorf, , Germany
Investigational Site Number : 2760004
Frankfurt, , Germany
Investigational Site Number : 2760001
Leipzig, , Germany
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000003
Athens, , Greece
Investigational Site Number : 3480005
Budapest, , Hungary
Investigational Site Number : 3480004
Debrecen, , Hungary
Investigational Site Number : 3480002
Székesfehérvár, , Hungary
Investigational Site Number : 3480001
Szigetvár, , Hungary
Buzzi Children's Hospital - Investigational Site Number : 3800003
Milan, Lombardy, Italy
Investigational Site Number : 3800005
Padua, Padova, Italy
Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002
Rome, Roma, Italy
AOU Luigi Vanvitelli - Investigational Site Number : 3800004
Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001
Pavia, , Italy
Investigational Site Number : 3920006
Isehara, Kanagawa, Japan
Investigational Site Number : 3920004
Tsu, Mie-ken, Japan
Investigational Site Number : 3920003
Ureshino, Saga-ken, Japan
Investigational Site Number : 3920002
Fukuoka, , Japan
Investigational Site Number : 3920001
Fukuoka, , Japan
Investigational Site Number : 4840001
San Juan del Río, Querétaro, Mexico
Investigational Site Number : 4840004
Durango, , Mexico
Investigational Site Number : 4840002
Veracruz, , Mexico
Investigational Site Number : 5280001
Rotterdam, , Netherlands
Investigational Site Number : 6160004
Tarnów, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160001
Lodz, Lódzkie, Poland
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 7240003
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Sabadell, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Jerez de la Frontera, Cádiz, Spain
Investigational Site Number : 7240005
Madrid, , Spain
Investigational Site Number : 7240004
Valencia, , Spain
Investigational Site Number : 8260003
Birmingham, England, United Kingdom
Investigational Site Number : 8260002
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260001
London, London, City of, United Kingdom
Investigational Site Number : 8260004
Bradford, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Facility Contacts
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Isabella Biondi
Role: backup
Related Links
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EFC14771 Plain Language Results Summary
Other Identifiers
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EFC14771
Identifier Type: -
Identifier Source: org_study_id
2023-504331-41
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1246-7432
Identifier Type: REGISTRY
Identifier Source: secondary_id
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