Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309823
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-02-23
Brief Title:
A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency
Status:
COMPLETED
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:
MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18 thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2 Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines including NLRC4-associated disease and hidradenitis suppurativa This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2 who has previously demonstrated response to blockade of IL-1 beta and IL-18 Given the lack of alternative pharmaceutical options for XLP-2 this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None