Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)
NCT ID: NCT06792487
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-09-04
2027-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sperimental
Patients affected by moderate-severe psoriasis treated with anti IL-23 therapy for at least 6 months, according to label dose.
skin biopsy
punch biopsy (6 mm) of lesional psoriasis skin
No Sperimental
Patients affected by moderate-severe psoriasis that have not been already treated
skin biopsy
punch biopsy (6 mm) of lesional psoriasis skin
Interventions
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skin biopsy
punch biopsy (6 mm) of lesional psoriasis skin
Eligibility Criteria
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Inclusion Criteria
* 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 with complete response to anti IL23, without resistant plaques or disease flare-ups
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Ketty Peris, Prof
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6215
Identifier Type: -
Identifier Source: org_study_id
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