Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum PG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Open-label Study Assessing Short-term Week 6 16 and Long-term Week 32 Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
GEORGE
Brief Summary:
A single-arm open-label study assessing short-term week 6 16 and long-term week 32 efficacy of guselkumab in adult participants with pyoderma gangrenosum PG
Detailed Description:
This is a Phase II study that will be open label and include a total of 17 patients who will receive the investigational product PG will be defined by the investigator on the basis of results from clinical histological and laboratory assessments These patients will undergo 28 weeks of guselkumab dosed every 4 weeks and a stable dose of prednisone dosed daily with follow-up until week 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None