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Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)
NCT06792487 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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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
About this study
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.
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
Study design
Enrollment target: 20 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-09-04
Estimated completion: 2027-01-01
Last updated: 2025-01-24
Interventions
Procedure: skin biopsy
Primary outcomes
- • Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion (through study completion, an average of 1 year)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · other
Contacts & investigators
ContactKetty Peris, Prof · contact · ketty.peris@policlinicogemelli.it · +390630155284
InvestigatorKetty Peris, Prof · principal_investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
All locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC DermatologiaRecruiting
Rome, Lazio, Italy