NCT06640114

Hemoperfusion With Efferon CT for the Treatment of Patients With Severe Psoriasis

A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Efferon JSC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 studies,we 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DEVICE	Efferon CT	Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa. The duration of hemoperfusion is from 2 to 6 hours through peripheral venous access, followed by follow-up for 4 hours. The rate of hemoperfusion is from 60 to 80 ml/min. Anticoagulation is systemic (heparin).

Timeline

• Start date: 2024-10-22
• Primary completion: 2025-04-14
• Completion: 2025-07-14
• First posted: 2024-10-15
• Last updated: 2025-11-24

Locations

2 sites across 1 country: Russia