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

Recruiting

• Conditions: Psoriasis

• Registration Number: NCT06792487
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-26
• Study Start: 2024-09-04
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-09-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Through 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 Outcome Measures

Name	Time	Method
immune biomarkers of sustained and prolonged response to treatment	through study completion, an average of 1 year	Identification 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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia; 🇮🇹 Roma, Lazio, Italy