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

Conditions

• Asthma
• Wheezing

Eligibility Criteria

Sex

ALL

Age

2 Years - 5 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study Details

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).

Key Dates

Start date

Jan 3, 2024

Status verified

Mar 2026

Primary completion

Dec 21, 2028

Completion

Dec 21, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab (double-blind period)
  Dupilumab subcutaneous injection as per protocol
• Placebo Comparator: Placebo
  Placebo matching dupilumab subcutaneous injection as per protocol

Primary Outcome Measure

Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period [ Time Frame: Baseline through Week 52 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (14)

Find similar trials in Phoenix, AZ

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