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Enrolling By Invitation
NCT06191315
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Conditions: Wheezing, Asthma
Sex: All
Ages: 2 Years – 5 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 90
Sponsor: Sanofi
Location: Phoenix Children's Hospital- Site Number : 8400001 Phoenix Arizona
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 \
Eligibility Criteria
Inclusion Criteria:
* Participant must be 2 to \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 \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 (\
Source: ClinicalTrials.gov (NCT06191315). StuddyBuddy aggregates publicly available trial information.