Who Can Participate?
Children 2 to under 6 years of age inclusive, with uncontrolled asthma and/or recurrent severe asthmatic wheeze, may be eligible.
Inclusion Criteria:
Participant Info:
How Long Will The Study Last?
Burlington - Halton Pediatric Allergy
No Doctors Found
Similar Trials
No Similar Trials FoundThe following information is from ClinicalTrials.gov
Last Update Posted: August 13, 2025
NCT06191315
Sanofi
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 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).
Condition or Disease:
Wheezing, Asthma
Intervention/Treatment:
Drug: Dupilumab Drug: PlaceboPhase:
PHASE 3
Ages Eligible for Study:
2 Years and 5 Years (CHILD)
Sexes Eligible for Study:
ALL
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