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Dupilumab for Asthma/Asthmatic Wheeze in Young Children

This study is looking at Dupilumab, an injection given under the skin, to see if it can help children aged 2 to under 6 years old who have uncontrolled asthma or frequent severe wheezing. Researchers want to find out if Dupilumab is safe and effective in reducing severe asthma attacks. You could be eligible if your child has asthma or recurrent severe wheezing that isn't well-controlled with their current inhaled steroid medicine. The study will compare Dupilumab to a placebo (an inactive injection) over 52 weeks. After this initial period, there's an option for participants to continue in an open-label extension phase, where everyone receives Dupilumab. The study aims to enroll about 90 children.

Study design
This is a Phase 3 study with two parts. Part A is a 52-week, randomized, double-blind (meaning neither you nor the doctors will know if your child is getting Dupilumab or placebo) study, followed by an optional open-label extension in Part B. About 90 participants are planned.
What's involved
Your child would participate for up to 120 weeks. Part A involves a 4-week screening, a 52-week treatment period, and a 12-week follow-up after treatment.
Compensation
Not stated in the trial record.
Follow-up
After the 52-week treatment period in Part A, there is a 12-week post-treatment follow-up period. For Part B, safety will be measured up to Week 116.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06191315

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Enrolling by Invitation
PHASE3Ages 2–5InterventionalTreatment
Sanofi
~90 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:DupilumabPlacebo

At a glance

Recruiting sites
0 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period
Measured over Baseline through Week 52
+1 more outcome measured

Conditions

Wheezing
Asthma

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AsthmaWheezingEosinophiliaIgE

Where it's being run

74 sites across 46 states
Argentina7
France5
Hungary4
Germany3
Barcelona [Barcelona]3
Florida2
New York2
Ohio2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

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:
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).

What this trial measures

  • Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment periodBaseline through Week 52

    Annualized rate of severe asthma exacerbations during the 52-week treatment period.

  • Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuationWeek 52 through Week 116

    Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.