Tests dupilumab injections in young children with asthma or severe wheezing
Tests dupilumab against placebo in children aged 2 to 5 with uncontrolled asthma.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Key facts
- Where
- Burlington, Edmonton, Hamilton, Montreal, Sherbrooke, and Vancouver, CanadaSee the 6 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 5 years old?
Source: NCT06191315, who can take part
Where in Canada
- BurlingtonBurlington, CanadaNo longer taking part
- EdmontonEdmonton, CanadaNo longer taking part
- HamiltonHamilton, CanadaNo longer taking part
- MontrealMontreal, CanadaNo longer taking part
- SherbrookeSherbrooke, CanadaNo longer taking part
- VancouverVancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT06191315EU 2023-504331-41-00
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze
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).
Inclusion: Participant must be 2 to <6 years of age; 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:; Physician diagnosed Atopic Dermatitis,; Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L); OR 2 minor criteria:; Wheezing unrelated to colds,; Peripheral blood eosinophilia ≥4%,; 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: 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; Participants are excluded from the study if any of the following criteria apply:.