Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03560466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-05
First Post:
2018-03-22
Brief Title:
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma Liberty Asthma Excursion
Sponsor:
Sanofi
Organization:
Sanofi
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-10
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003317-25 | EUDRACT_NUMBER | None | None |
| U1111-1200-1757 | OTHER | UTN | None |