Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Public ClinicalTrials.gov record NCT06191315. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06191315
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 90 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Years to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 3, 2024 (Actual)
- Primary completion
- Dec 21, 2028 (Estimated)
- Completion
- Dec 21, 2028 (Estimated)
- Last update posted
- Aug 13, 2026
2024 – 2028
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital- Site Number : 8400001 | Phoenix | Arizona | 85016 | — |
| Allervie Clinical Research - Destin- Site Number : 8400016 | Destin | Florida | 32541 | — |
| EMDA Clinical Research- Site Number : 8400026 | Miami | Florida | 33126 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011 | Chicago | Illinois | 60611 | — |
| Allergy and Asthma Specialist- Site Number : 8400002 | Owensboro | Kentucky | 42301 | — |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 | Rochester | Minnesota | 55905 | — |
| UBMD Pediatrics- Site Number : 8400013 | Buffalo | New York | 14203 | — |
| Boston Children's Health Physicians - Hawthorne- Site Number : 8400010 | Hawthorne | New York | 10532 | — |
| UNC Children's Hospital- Site Number : 8400005 | Chapel Hill | North Carolina | 27514 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400004 | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland Medical Center- Site Number : 8400015 | Cleveland | Ohio | 44106 | — |
| Vanderbilt University Medical Center- Site Number : 8400024 | Nashville | Tennessee | 37232 | — |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400022 | Boerne | Texas | 78006 | — |
| Texas Children's Hospital- Site Number : 8400027 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06191315, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06191315 live on ClinicalTrials.gov.