Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT03560466
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2018-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Detailed Description:
Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.
Japan substudy:
Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.
Japan substudy:
Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: