Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
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
Sanofi
90 participants
Jan 3, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria14
- 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 Criteria7
- 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.
Interventions
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Locations(75)
View Full Details on ClinicalTrials.gov
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NCT06191315