PsoriasisNCT06640114
Hemoperfusion With Efferon CT for the Treatment of Patients With Severe Psoriasis
A study testing Efferon CT in people with Psoriasis, run by Efferon JSC at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Efferon CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- 22 Oct 2024to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency
Saint Petersburg, 194291
North-Western State Medical University named after I.I. Mechnikov (NWSMU)
Saint Petersburg
About this study
Official title: A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis
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.
Read the 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
- Being tested
- Efferon CT
- Keywords
- Psoriasis, Hemoperfusion, Extracorporeal therapy, Cytokine adsorption
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon CTDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Efferon CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PASI (Psoriasis Area and Severity Index) score
Amount of PASI value reduction, %
Measured: 0 - 90 days
Change in BSA (Body surface area) score
Amount of BSA value reduction, %
Measured: 0 - 90 days
Change in the Dermatology Life Quality Index (DLQI) score
Amount of DLQI value reduction, %
Measured: 0 - 90 days
Secondary outcomes (4)
Effect of hemoperfusion using Efferon CT on the severity of pruritus according to the Visual Analogue Scale (VAS)
Change in Visual Analogue Scale (VAS) score, %
Measured: 0-90 days
Researchers' satisfaction with treatment efficacy and side effects of Efferon CT device in treating psoriasis patients
Continuous Hemoperfusion Index-Effectiveness Index (CGI-E)
Measured: 1-90 days
Safety of the Efferon CT device in patients with psoriasis
Frequency of incidents and adverse events
Measured: 1-14 days
Researchers' global impression with the use of the Efferon CT device in the treatment of patients with psoriasis
Global Improvement Scale (CGI-I)
Measured: 1-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Oct 2024
- Primary completion14 Apr 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konstantin Raznatovsky, PhD, MD, Principal investigator, North-Western State Medical University named after I.I. Mechnikov (NWSMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640114
- Sponsor's protocol ID
- efferon-ct-2024-02
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis
- ClinicalTrials.gov ID
- NCT06640114
- Acronym / sponsor ID
- efferon-ct-2024-02
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Hemoperfusion, Extracorporeal therapy, Cytokine adsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Efferon CTPatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon CTEfferon 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). | Device | Baseline therapy + Efferon CT |
Primary outcome
Change in PASI (Psoriasis Area and Severity Index) score
Time frame: 0 - 90 days
Amount of PASI value reduction, %
Change in BSA (Body surface area) score
Time frame: 0 - 90 days
Amount of BSA value reduction, %
Change in the Dermatology Life Quality Index (DLQI) score
Time frame: 0 - 90 days
Amount of DLQI value reduction, %
4 secondary outcomes
Effect of hemoperfusion using Efferon CT on the severity of pruritus according to the Visual Analogue Scale (VAS)
Time frame: 0-90 days
Researchers' satisfaction with treatment efficacy and side effects of Efferon CT device in treating psoriasis patients
Time frame: 1-90 days
Safety of the Efferon CT device in patients with psoriasis
Time frame: 1-14 days
Researchers' global impression with the use of the Efferon CT device in the treatment of patients with psoriasis
Time frame: 1-90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin Raznatovsky, PhD, MD principal investigator
North-Western State Medical University named after I.I. Mechnikov (NWSMU)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon CT in people with Psoriasis, run by Efferon JSC at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PASI (Psoriasis Area and Severity Index) score (time frame: 0 - 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.