RecruitingWheezingAsthma

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

Eligible age

2–5 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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).

Sponsor: Sanofi

You may qualify if…

✓ 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:
✓ 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%,

You may not qualify if…

✕ Participants are excluded from the study if any of the following criteria apply:
✕ 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.