Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
378actual
Sites
81
Countries
Argentina, Australia, Brazil +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-06-21 | actual | When the study began enrolling |
| Primary completion | 2025-04-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-01 | actual | The whole study's end, after follow-up |
| First posted | 2018-06-18 | actual | When this record first appeared on the registry |
| Results posted | 2025-11-21 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-11-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Asthma
Interventions
- Drug: Dupilumab (SAR231893/REGN668)
- Drug: Asthma controller therapies (incl. prednisone/prednisolone)
- Drug: Asthma reliever therapies
Primary outcomes
what the primary-completion date above is the date OFMain Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
measured From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
measured Baseline (Day 1) to Week 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-12-21 · 2.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-06-25 · 2.1 MB · SAP_001.pdf
Publications
- PMID 37956679 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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