Status:
RECRUITING
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Wheezing
Asthma
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief 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 asthmat...
Detailed Description
The duration per participant is up to 120 Weeks.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06191315
Start Date
January 3 2024
End Date
December 21 2028
Last Update
December 10 2025
Active Locations (74)
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1
Phoenix Children's Hospital- Site Number : 8400001
Phoenix, Arizona, United States, 85016
2
Allervie Clinical Research - Destin- Site Number : 8400016
Destin, Florida, United States, 32541
3
EMDA Clinical Research- Site Number : 8400026
Miami, Florida, United States, 33126
4
Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011
Chicago, Illinois, United States, 60611