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NCT03560466 · ClinicalTrials.gov registry record · Phase 3
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 378
- Enrollment target
NCT03560466: Completed Phase 3 study, sponsored by Sanofi.
NCT03560466 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 378 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03560466, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 378 participants
- Enrollment target
Study Summary
Primary Objective: * To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: * To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: * Systemic exposure. * Anti-drug antibodies (ADAs). * Biomarkers. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.
Interventions
- DRUG Dupilumab (SAR231893/REGN668)
- DRUG Asthma controller therapies (incl. prednisone/prednisolone)
- DRUG Asthma reliever therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 3 |
What the finished NCT03560466 record still lists
NCT03560466 is an interventional study that assigns participants to a tested intervention. The registered 378 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which Dupilumab (SAR231893/REGN668) is the first listed.
NCT03560466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03560466 about?
NCT03560466 is a clinical study titled "Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)". Primary Objective: * To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in ...
What is the current status of trial NCT03560466?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 378 participants. The study started on 2018-06-21. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT03560466?
The interventions under investigation include: Dupilumab (SAR231893/REGN668) (DRUG), Asthma controller therapies (incl. prednisone/prednisolone) (DRUG), Asthma reliever therapies (DRUG).
Who is sponsoring clinical trial NCT03560466?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03560466's enrollment target sits among peer trials
378 988th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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