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

Launched by SANOFI · Dec 19, 2023

Keywords

ClinConnect Summary

The LIBERTY ASTHMA TREKIDS clinical trial is studying the effectiveness and safety of a medication called dupilumab in young children aged 2 to less than 6 years who have asthma or frequently wheeze and are not responding well to their current asthma treatments. The study is divided into two parts. In the first part, which lasts about a year, children will be randomly assigned to receive either dupilumab or a placebo (a treatment without the active medication) to see how well it works and what side effects it might cause. After this initial phase, children who qualify will have the option to continue in a second part for another year, where everyone will receive the active treatment.

To join the study, children must be between 2 and 6 years old, have been diagnosed with asthma that isn’t well-controlled, and meet certain other health criteria. Parents or caregivers will need to be involved, attending clinic visits and helping with study-related tasks. Throughout the study, families can expect regular check-ups, and there will be follow-up time after treatment to monitor how the children are doing. This trial aims to find better options for managing asthma in young kids, making it an important step in improving their health and quality of life.

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Eligibility criteria

• 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.