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

NCT06640114 | Completed

• 1 other identifier: efferon-ct-2024-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Keywords

Psoriasis; Hemoperfusion; Extracorporeal therapy; Cytokine adsorption

Outcome Measures

Primary Outcomes (3)

• Change in PASI (Psoriasis Area and Severity Index) score

  Amount of PASI value reduction, %

  0 - 90 days

• Change in BSA (Body surface area) score

  Amount of BSA value reduction, %

  0 - 90 days

• Change in the Dermatology Life Quality Index (DLQI) score

  Amount of DLQI value reduction, %

  0 - 90 days

Secondary Outcomes (4)

• Effect of hemoperfusion using Efferon CT on the severity of pruritus according to the Visual Analogue Scale (VAS)

  0-90 days

• Researchers' satisfaction with treatment efficacy and side effects of Efferon CT device in treating psoriasis patients

  1-90 days

• Safety of the Efferon CT device in patients with psoriasis

  1-14 days

• Researchers' global impression with the use of the Efferon CT device in the treatment of patients with psoriasis

  1-90 days

Study Arms (2)

Baseline therapy

NO INTERVENTION

Patients who received only standard therapy according to the underlying disease (topical therapy, systemic therapy, phototherapy).

Baseline therapy + Efferon CT

EXPERIMENTAL

Patients with moderate to severe psoriasis who were receiving standard therapy for the treatment of the underlying disease and who also received a single course of haemoperfusion with Efferon CT

Device: Efferon CT

Interventions

Efferon CT DEVICE

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).

Baseline therapy + Efferon CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to provide written informed consent and willingness and ability to comply with all requirements of the clinical trial design.
• to 70 years of age.
• moderate to severe psoriasis (plaque psoriasis without psoriatic arthritis) with a disease duration of at least 6 months.
• should be receiving standard psoriasis therapy according to clinical recommendations (topical therapy, systemic therapy, phototherapy).
• Psoriasis Area and Severity Index (PASI) score ≥10,
• Body surface area (BSA) affected by psoriasis ≥10%,
• Dermatology Life Quality Index (DLQI) score \>10 points,
• physician's global assessment of psoriasis severity using the static Physician Global Assessment (sPGA) ≥3 points,
• Dermatological Disease Severity Index (DIDS) score ≥2.

You may not qualify if:

• patients with other forms of psoriasis (e.g. psoriatic erythroderma, pustular psoriasis, scale psoriasis, psoriatic arthritis) or other skin conditions (e.g. eczema).
• patients on genetically engineered biological therapy (GEBT) for psoriasis.
• patients with mild forms of psoriasis.
• patients with HIV infection, syphilis, acute infectious diseases, tuberculosis.
• patients with oncological diseases.
• patients with chronic diseases in the stage of decompensation.
• patients with thrombosis and recurrent thromboembolism, thrombophlebitis.
• female patients who are pregnant or breastfeeding.
• age of patients younger than 18 years and older than 70 years.
• in the opinion of the investigator, inability of the subject to participate in this study for any other reason.
• mental condition in which the subject is unable to understand the nature, purpose and possible implications of this research.
• history of allergy, hypersensitivity to components of the extracorporeal circuit.
• inability or unwillingness to undergo all follow-up procedures until the end of the study and/or unwillingness to allow access to their medical records in accordance with national regulatory requirements at the time of consent.
• Charlson Index score greater than 6.

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (2)

North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency

Saint Petersburg, 194291, Russia

Location

North-Western State Medical University named after I.I. Mechnikov (NWSMU)

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Konstantin Raznatovsky, PhD, MD

  North-Western State Medical University named after I.I. Mechnikov (NWSMU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation of patients into groups will be done by stratified 1:1 randomisation. Stratification will be done by the patient's PASI index score (10 to 19, and more than 19).

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: October 22, 2024
• Primary Completion: April 14, 2025
• Study Completion: July 14, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

RU (2)