Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599697
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
The MIGHT Trial - an Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The MIGHT Trial - an Exploratory Clinical Trial of Intravenous Immunoglobulin IVIG in Anti-3-Hydroxy-3-Methylglutaryl-CoA Reductase HMGCR Immune Mediated Necrotizing Myopathy IMNM
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 a randomized placebo-controlled double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin IVIG in anti-3-hydroxy-3-methylglutaryl-CoA reductase HMGCR immune mediated necrotizing myopathy IMNM Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria Assuming 20 drop-out the investigators anticipate 10 participants will complete all study assessments Enrolled participants will be randomized 11 to either IVIG 2gkg or placebo 09 sodium chloride at equivalent volume at weeks 0 4 and 8 The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12 After the randomized phase of the trial all participants except those who were randomized to IVIG and met the clinical deterioration criteria will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12 16 and 20 Participants will then return at week 24 for a final non-infusion visit to reassess safety tolerability and efficacy outcome
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