Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-02 @ 3:59 AM
Study NCT ID:
NCT03646604
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2025-02
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:
The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-004409-17 | EUDRACT_NUMBER | None | View |