NCT06640114Completed
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
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Oct 2024
- Start date
- 22 Oct 2024
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- Efferon JSC
- Diseases
- Psoriasis
- NCT number
- NCT06640114
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 22 Oct 2024 to the primary completion date, 14 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients on genetically engineered biological therapy (GEBT) for psoriasis.
Other illness
- patients with other forms of psoriasis (e.g. psoriatic erythroderma, pustular psoriasis, scale psoriasis, psoriatic arthritis) or other skin conditions (e.g. eczema).
- 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.
- 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.
Age
- age of patients younger than 18 years and older than 70 years.
Other
- patients with mild forms of psoriasis.
- female patients who are pregnant or breastfeeding.
- in the opinion of the investigator, inability of the subject to participate in this study for any other reason.
- 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.
Who the study is looking for
- ability to provide written informed consent and willingness and ability to comply with all requirements of the clinical trial design.
- 18 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.
- for female patients: postmenopausal or have a negative pregnancy test (urinalysis) prior to enrolment. If urinalysis does not confirm absence of pregnancy, an appropriate serum analysis should be performed. The subject's pregnancy test must be negative to be eligible for inclusion in the study.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North-Western State Medical University named after I.I. Mechnikov (NWSMU) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.