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Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
NCT06191315 · View on ClinicalTrials.gov ↗
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).
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
Other
- Investigational Site Number : 0320008 — Buenos Aires
- Investigational Site Number : 0320003 — Buenos Aires
- Investigational Site Number : 0320002 — Buenos Aires
- Investigational Site Number : 0320001 — Buenos Aires
- Investigational Site Number : 0320009 — Corrientes
Florida
- Allervie Clinical Research - Destin- Site Number : 8400016 — Destin
- EMDA Clinical Research- Site Number : 8400026 — Miami
New York
- UBMD Pediatrics- Site Number : 8400013 — Buffalo
- Boston Children's Health Physicians - Hawthorne- Site Number : 8400010 — Hawthorne
Ohio
- Cincinnati Children's Hospital Medical Center- Site Number : 8400004 — Cincinnati
- University Hospitals Cleveland Medical Center- Site Number : 8400015 — Cleveland
Texas
- South Texas Medical Research Institute - TTS Research- Site Number : 8400022 — Boerne
- Texas Children's Hospital- Site Number : 8400027 — Houston
Arizona
- Phoenix Children's Hospital- Site Number : 8400001 — Phoenix
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011 — Chicago
Kentucky
- Allergy and Asthma Specialist- Site Number : 8400002 — Owensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-01-03 |
| Est. Completion | 2028-12-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06191315
The ClinicalTrials.gov registry entry for NCT06191315 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06191315 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06191315 about?
NCT06191315 is a clinical study titled "Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)". 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-blin...
What is the current status of trial NCT06191315?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2024-01-03. Estimated completion is 2028-12-21.
What conditions does trial NCT06191315 study?
This clinical trial studies the following conditions: Asthma, Wheezing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06191315?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06191315?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06191315 being conducted?
This trial has 20 study locations across Arizona, Florida, Illinois, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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