Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skin biopsy.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
Overview
Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques. Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development. Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy. Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.
Interventions
- Procedure skin biopsy
punch biopsy (6 mm) of lesional psoriasis skin
Primary outcome measures
- Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- immune biomarkers of sustained and prolonged response to treatment [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- moderate-severe psoriasis PASI>10
- anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
- during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
- patients able to express informed consent
Exclusion criteria
- patients unable to express informed consent
- patients with complete response to anti IL23, without resistant plaques or disease flare-ups
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia — Rome
Identifiers
NCT: NCT06792487 · 6215