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

Investigating the Safety and Efficacy of an Investigational Medication in Young Children with Asthma

Recruiting
2 years - 5 years
All
Phase 3
90 participants needed
5 Locations

Study Overview

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).

Study Details

The duration per participant is up to 120 Weeks.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Wheezing, Asthma
  • Age: 2 years - 5 years
  • Gender: All

Inclusion Criteria:

  • 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%,
    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:

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 dupilumab or any other 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.

Updated on 13 Mar 2025. Study ID: NCT06191315

This study investigates the effects of an investigational medication on young children aged 2 to under 6 years who have uncontrolled asthma or recurrent severe asthmatic wheezing. Asthma is a condition where the airways in the lungs become narrow and swollen, making it hard to breathe. This study will help understand how safe and effective the investigational medication is for these children.

Participants in the study will be randomly assigned to one of two study arms. One arm will receive the investigational medication, while the other will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will be conducted in two parts: Part A, which is a placebo-controlled phase, and Part B, an optional open-label extension where all participants can receive the investigational medication.

  • Who can participate: Children aged 2 to under 6 years with uncontrolled asthma or severe wheezing who have been using inhaled corticosteroids for at least 3 months may participate. They must also meet certain health criteria, such as having atopic dermatitis or specific allergic sensitizations.
  • Study details: Participants will take part in a randomized study where they will receive either the investigational medication or a placebo. The study includes a screening period, treatment phase, and follow-up.
  • Study Timelines: The study will last up to 120 weeks.

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