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

NCT06792487 | Recruiting

• 1 other identifier: 6215
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• immune biomarkers of sustained and prolonged response to treatment

  through study completion, an average of 1 year

Study Arms (2)

Sperimental

Patients affected by moderate-severe psoriasis treated with anti IL-23 therapy for at least 6 months, according to label dose.

Procedure: skin biopsy

No Sperimental

Patients affected by moderate-severe psoriasis that have not been already treated

Procedure: skin biopsy

Interventions

skin biopsy PROCEDURE

punch biopsy (6 mm) of lesional psoriasis skin

No Sperimental; Sperimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by moderate-severe psoriasis under anti IL-23 therapy

You may qualify if:

• 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

You may not qualify if:

• patients unable to express informed consent
• patients with complete response to anti IL23, without resistant plaques or disease flare-ups

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ketty Peris, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketty Peris, Prof

CONTACT

+390630155284; ketty.peris@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: January 24, 2025
• Study Start: September 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

IT (1)