AUTOANTIBODIES AND SYSTEMIC SCLEROSIS

ConditionUnderstand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorIRCCS Ospedale San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

positivity of autoantibodies

Disqualifiers

pregnant

Trial population

systemic sclerosis patients characterised by the autoantibody positivity

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Fcr blocker of autoantibodies
Biological/Vaccine
in vitro assays, combined with multi-omics approach and in vitro experimental models, will gain insights into the pathogenesis of Systemic Sclerosis (SSc)dissecting the consequences of treatment with Fcblocker on functional and phenotypic cell behavior. 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 effect

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Verify if Fcblocker can block the pathogenic activity of autoantibodies

To assess both the prevention and the recovery capacity of the FcR blocker in different kind of cells submitted to the specific autoantibody. microvascular endothelial cells and fibroblasts

Time frame

24 months

Locations

This trial has no locations.

Sponsors and contacts

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IRCCS Ospedale San Raffaele

Lead sponsor

Source ClinicalTrials.gov

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