Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502678
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
AUTOANTIBODIES AND SYSTEMIC SCLEROSIS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Systemic Sclerosis the Role of Autoantibodies and Their Blockade in the Disease Pathogenesis In Vitro and in Vivo Experimental Models
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
AUTO
Brief Summary:
Established in vitro assays combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models will gain insights into the mechanistic bases underlying Systemic Sclerosis SS pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors Healthy microvascular endothelial cells fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker The putative modulatory effect of Efgartigimod on vascular remodeling endothelial-to-mesenchymal transition fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects
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