Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617793
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
An Open-label Study to Assess the Safety Efficacy and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multi-center Phase 12 Study to Assess Safety Efficacy and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy
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:
This is an open-label multi-center non-confirmatory study to assess the safety efficacy and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis RMS with breakthrough disease activity during previous treatment with a highly efficacious therapy BD-HET The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort
Detailed Description:
All participants in this study will receive YTB323 Both the participant and the study doctor will know the participant is getting YTB323 Participants will be given one dose of YTB323 Different groups of participants may receive a higher dose of YTB323 if proven to be safe for every participant at the lower dose Participants are in this study for 2 years and will be followed for an additional 13 years in a long-term follow up study The main question this trial is designed to answer Is YTB323 treatment safe for participants with relapsing MS
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