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Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)

Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06792487
Enrollment
20
Registered
2025-01-24
Start date
2024-09-04
Completion date
2027-01-01
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

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

PROCEDUREskin biopsy

punch biopsy (6 mm) of lesional psoriasis skin

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesionthrough study completion, an average of 1 yearThrough the integration of multiparametric immunofluorescence staining with RNA in situ hybridization technology, our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one lesion psoriatic lesion in patients with moderate-severe psoriasis, undergoing treatment with anti-IL-23.

Secondary

MeasureTime frameDescription
immune biomarkers of sustained and prolonged response to treatmentthrough study completion, an average of 1 yearIdentification of possible immune biomarkers of sustained and prolonged response to anti-IL-23 biological therapy that will include the expression profile of biomarkers related to tissue immune memory.

Countries

Italy

Contacts

Primary ContactKetty Peris, Prof
ketty.peris@policlinicogemelli.it+390630155284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026