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

About the trial

Sponsor

Sanofi (with Regeneron Pharmaceuticals)

Tested

Dupilumab (drug), Placebo (drug)

Dates

Started 2024-01-03; completion 2028-12-21

Results posted

Not yet

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 consist…

From ClinicalTrials.gov, last updated 2026-08-13. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $715,941 in research payments for this study in 2025 (98 payments).

Products named: Dupixent

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.