Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625177
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Open-Label Trial to Assess Safety and Efficacy of TEV-53408 in Participants With Vitiligo
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo
Another primary objective is to evaluate the efficacy of TEV-53408
A secondary objective is to further evaluate the safety of TEV-53408
The planned study period per participant is 84 weeks including a screening period up to 4 weeks a 24-week open-label treatment period a 16-week washout period and a 40-week follow-up period
Another primary objective is to evaluate the efficacy of TEV-53408
A secondary objective is to further evaluate the safety of TEV-53408
The planned study period per participant is 84 weeks including a screening period up to 4 weeks a 24-week open-label treatment period a 16-week washout period and a 40-week follow-up period
Detailed Description:
None
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