NCT06191315

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

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The duration per participant is up to 120 Weeks.

Conditions

• Wheezing
• Asthma

Interventions

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form: Injection solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Timeline

• Start date: 2024-01-03
• Primary completion: 2028-12-21
• Completion: 2028-12-21
• First posted: 2024-01-05
• Last updated: 2026-03-20

Locations

74 sites across 16 countries: United States, Argentina, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study