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 Uncontrolled Asthma, a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe

Recruiting
2 years - 5 years
All
Phase 3
90 participants needed
14 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 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 24 Apr 2025. Study ID: NCT06191315

This study investigates the safety and effectiveness of an investigational medication in children aged 2 to under 6 years who have uncontrolled asthma or experience frequent severe wheezing. Uncontrolled asthma means that the usual treatments are not enough to manage the symptoms. The study is divided into two parts. Part A involves a 52-week period where children will receive either the investigational medication or a placebo, which is a substance that looks like the medication but does not contain any active ingredients.

Participants will undergo various procedures during the study, including regular health check-ups and assessments to monitor their asthma symptoms and overall health. Part B is an optional extension phase where all participants from Part A can choose to continue receiving the investigational medication for an additional 52 weeks. This is to further evaluate the long-term safety and effects of the medication.

  • Who can participate: Children aged 2 to under 6 years with uncontrolled asthma or severe wheezing may participate. Eligibility requires prior use of inhaled corticosteroids for at least 3 months and specific health criteria, such as having atopic dermatitis or certain allergies.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. Regular visits will monitor health and asthma symptoms.
  • Study Timelines: The study will last up to 120 weeks.

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