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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 378 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03560466
The ClinicalTrials.gov registry entry for NCT03560466 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 378 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dupilumab (SAR231893/REGN668) is the first listed.
NCT03560466 reports 0 study locations.
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.
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