Treatment of severe psoriasis using hemoperfusion with Efferon CT
A Randomised Pilot Study of the Efficacy and Safety of Using Hemoperfusion With Efferon CT to Treat Patients With Severe Psoriasis
This study is testing if a new treatment called hemoperfusion with Efferon CT can help people with severe psoriasis feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06640114 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of hemoperfusion with Efferon CT to treat patients suffering from severe psoriasis. The approach focuses on the non-specific adsorption of excess cytokines and inflammatory mediators that contribute to the disease's pathology. Eligible participants must have moderate to severe plaque psoriasis and be receiving standard therapy. The study aims to evaluate the efficacy of this extracorporeal therapy in reducing psoriasis severity and improving patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with moderate to severe plaque psoriasis and a PASI score of 10 or higher.
Not a fit: Patients with psoriatic arthritis or those not currently receiving standard psoriasis therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of psoriasis and improve the quality of life for affected patients.
How similar studies have performed: While the approach of cytokine adsorption is promising, it remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Saint Petersburg
- North-Western State Medical University named after I.I. Mechnikov (NWSMU) — Saint Petersburg, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Konstantin Raznatovsky, PhD, MD — North-Western State Medical University named after I.I. Mechnikov (NWSMU)
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +79636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.