Last updated 24 days ago
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
90 patients around the world
Available in Argentina, United States
The duration per participant is up to 120 Weeks.
Sanofi
90Patients around the world
This study is for people with
Asthma
Childhood asthma
Requirements for the patient
To 5 Years
All Gender
Medical requirements
- 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.
- 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).
SponsorSanofi
Conditions
Childhood asthma
Requirements
To 5 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06191315
