Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564311
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis MoonStone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
Status:
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:
None
Brief Summary:
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Detailed Description:
The study consists of a Screening Period Day -28 to Day -1 a 24-week treatment period Part A and Part B and an expected 12-week Follow-up Period Patients with Relapsing Multiple Sclerosis will be randomized in 21 ratio to obexelimab or placebo Randomization will be stratified by Gd lesion status at screening 1 vs 0
Part A is the 12-week Randomized Placebo-Controlled Period RCP during which obexelimab or placebo will be administered as weekly subcutaneous SC injections Following Part A all patients will enter the Part B Open-Label Period OLP during which all patients will receive obexelimab administered as weekly SC injections Patients will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part B ie Week 36 If at this time B cells have not returned to baseline or above the lower limit of normal LLN patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN at minimum The maximum expected duration of the study is 40 weeks Screening Period 4 weeks Parts A and B 24 weeks Follow-up Period 12 weeks
Part A is the 12-week Randomized Placebo-Controlled Period RCP during which obexelimab or placebo will be administered as weekly subcutaneous SC injections Following Part A all patients will enter the Part B Open-Label Period OLP during which all patients will receive obexelimab administered as weekly SC injections Patients will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part B ie Week 36 If at this time B cells have not returned to baseline or above the lower limit of normal LLN patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN at minimum The maximum expected duration of the study is 40 weeks Screening Period 4 weeks Parts A and B 24 weeks Follow-up Period 12 weeks
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