Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT02904902
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa
Status:
COMPLETED
Status Verified Date:
2020-04
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:
This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).
Detailed Description:
Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in United States (US) and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.
Study Oversight
Has Oversight DMC:
False
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?: