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NCT06191315 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
A Phase 3 study of Asthma and Wheezing, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06191315: Recruiting Phase 3 study of Asthma and Wheezing, sponsored by Sanofi.
NCT06191315 is a Phase 3 study of Asthma and Wheezing that is actively recruiting participants, run by Sanofi. The registered enrollment target is 90 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191315, a Phase 3 study of Asthma and Wheezing, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT06191315 shows while recruiting
NCT06191315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (94% lower).
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.
NCT06191315 names 20 study sites across 12 states, led by Other, Florida, New York.
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.
What interventions are being tested in trial NCT06191315?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT06191315?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06191315's enrollment target sits among peer trials
90 221st of 374 higher than 154 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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