AUTOANTIBODIES AND SYSTEMIC SCLEROSIS

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.

NCT Number	NCT06502678
Lead Sponsor	IRCCS Ospedale San Raffaele
Conditions	Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro
Enrollment	6 participants
Start Date	2024-09-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-07-16