Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 10:53 PM
Study NCT ID:
NCT04061395
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
HiGUS
Brief Summary:
This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.
The total duration of the treatment period per subject is 16 weeks.
The total duration of the treatment period per subject is 16 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: