Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678882
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2020-12-17
Brief Title:
Dupilumab in Japanese Patients With Atopic Dermatitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Parallel-group Study to Evaluate the Efficacy Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to 18 Years Whose Disease is Not Adequately Controlled With Existing Therapies
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids TCS
Secondary Objective
To evaluate the efficacy of dupilumab administered concomitantly with TCS To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants
To assess immunogenicity as determined by the incidence titer and clinical impact of treatment-emergent anti-drug antibodies ADA to dupilumab over time in pediatric patients with atopic dermatitis AD aged 6 months to 18 years old To assess the concentration of dupilumab in serum following administration concomitantly with TCS
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids TCS
Secondary Objective
To evaluate the efficacy of dupilumab administered concomitantly with TCS To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants
To assess immunogenicity as determined by the incidence titer and clinical impact of treatment-emergent anti-drug antibodies ADA to dupilumab over time in pediatric patients with atopic dermatitis AD aged 6 months to 18 years old To assess the concentration of dupilumab in serum following administration concomitantly with TCS
Detailed Description:
For participant who declines to enter open-lebal extension OLE the duration of the study for each participant is approximately 33 weeks including screening and follow-up For participant choosing enter OLE the duration is approximately 21 weeks including screening plus 3 years OLE period or until approval of the indication in Japan whichever is sooner
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2020-002601-26 | EUDRACT_NUMBER | ICTRP | None |
| U1111-1301-1257 | REGISTRY | None | None |