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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dupilumab: Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Placebo: Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study 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).

Eligibility

Primary outcome measure(s)

• Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period — Baseline through Week 52
  Annualized rate of severe asthma exacerbations during the 52-week treatment period.
• Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation — Week 52 through Week 116
  Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.

Trial sites (74)

+ 34 more sites — see the full list on the official registry below.