Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326476
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
An Open-label Parallel Group Pilot Study to Demonstrate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa
Detailed Description:
Subjects will be assigned to receive seven subcutaneous doses of siplizumab over an 8 week period 12 subjects will be given 40 mg weekly from baseline week 0 to week 4 and a 40 mg dose at weeks 6 and 8 Assessments will be performed weekly from baseline week 0 through week 6 and biweekly through week 12 weeks 8 10 12 by an investigator Weeks 5 and 10 will be telephone visits and will not include physician HS assessments All other visits will be conducted in person During all visits subjects will also be asked to complete a quality of life questionnaire DLQI and Visual Analog Scale VAS for pain assessment
A total enrollment of 12 subjects is anticipated in this pilot study
A total enrollment of 12 subjects is anticipated in this pilot study
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000544067 | OTHER | University of Alabama at Birmingham | None |