Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640114
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Hemoperfusion With Efferon CT for the Treatment of Patients With Severe Psoriasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Psoriasis is a chronic inflammatory skin condition driven by the immune system marked by red scaly plaques that commonly affect the scalp and nails About 30 of psoriasis patients may develop psoriatic arthritis especially those with severe psoriasis or lesions on the nails or scalp Research has identified distinct cytokine gene expression patterns in skin versus synovial tissue which may explain the differing responses to biologic therapies in these areas Factors such as genetic predisposition infections obesity and biomechanical stress can trigger disease onset leading to the release of cytokines that activate both the innate and adaptive immune responses This immune activation can cause synovitis enthesitis erosions and lesions in both articular cartilage and skin
Given the reviewed literature and evidence that hemoperfusion with Efferon CT can non-specifically adsorb excess cytokines and inflammatory mediators our research team hypothesizes that cytokine sorption could have beneficial clinical effects for patients with severe and moderate psoriasis This study aims to evaluate the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for treating these patients
Given the reviewed literature and evidence that hemoperfusion with Efferon CT can non-specifically adsorb excess cytokines and inflammatory mediators our research team hypothesizes that cytokine sorption could have beneficial clinical effects for patients with severe and moderate psoriasis This study aims to evaluate the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for treating these patients
Detailed Description:
Psoriasis is a chronic inflammatory immune-mediated skin disease characterised by the appearance of erythematous and scaly plaques often involving the scalp and nails Approximately 30 of patients with psoriasis may develop psoriatic arthritis particularly in patients with severe psoriasis or lesions on the nails or scalp and a different cytokine gene expression pattern has been identified between skin and synovial tissue explaining the differences in response to biologic therapy between these clinical areas A predisposing genetic background infections obesity or biomechanical factors act as triggers and accelerate disease onset by activating macrophages which present antigens via major histocompatibility complex type I to T cells mainly T lymphocytes CD8 via toll-like receptor type 2 This promotes the local release of cytokines that trigger the innate and adaptive immune response
IL-12 and TNF-α stimulate a T helper cell 1 response that releases TNF-α and INF-γ IL-23 TNF-ß IL-6 and IL-1b activate the T helper cell 17 response in the presence of IL-23 leading to the release of IL-17 mainly isoform A IL-22 IL-26 and CCL20 macrophage inflammatory protein-3α In addition regulation and deactivation of the inflammatory cascade requires a T-regulatory cell mediated response via IL-2 and TNF-ß These released cytokines interact with their transmembrane receptors promoting the release of more cytokines and the recruitment of endothelial cells macrophages fibroblasts keratinocytes dendritic cells epithelial cells chondrocytes osteoclasts and osteoblasts Activation of the immune system results in synovitis enthesitis erosions and lesions of articular cartilage and skin
Based on the literature data reviewed and the fact that Efferon CT hemoperfusion provides non-specific adsorption of excess cytokines and other inflammatory mediators as demonstrated in numerous clinical studieswe hypothesised that cytokine sorption may have a positive clinical impact in severe and moderate forms of psoriasis The aim of this study is to determine the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for the treatment of patients with severe and moderate psoriasis
IL-12 and TNF-α stimulate a T helper cell 1 response that releases TNF-α and INF-γ IL-23 TNF-ß IL-6 and IL-1b activate the T helper cell 17 response in the presence of IL-23 leading to the release of IL-17 mainly isoform A IL-22 IL-26 and CCL20 macrophage inflammatory protein-3α In addition regulation and deactivation of the inflammatory cascade requires a T-regulatory cell mediated response via IL-2 and TNF-ß These released cytokines interact with their transmembrane receptors promoting the release of more cytokines and the recruitment of endothelial cells macrophages fibroblasts keratinocytes dendritic cells epithelial cells chondrocytes osteoclasts and osteoblasts Activation of the immune system results in synovitis enthesitis erosions and lesions of articular cartilage and skin
Based on the literature data reviewed and the fact that Efferon CT hemoperfusion provides non-specific adsorption of excess cytokines and other inflammatory mediators as demonstrated in numerous clinical studieswe hypothesised that cytokine sorption may have a positive clinical impact in severe and moderate forms of psoriasis The aim of this study is to determine the efficacy and safety of anticytokine hemoperfusion using the Efferon CT device for the treatment of patients with severe and moderate psoriasis
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