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NCT Number: NCT06792487

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Kettu Peris, Prof

CONTACT

[email protected]

+390630155284

Ketty Peris, Prof

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin biopsy

Procedure

punch biopsy (6 mm) of lesional psoriasis skin

Primary outcomes

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

    Time frame: 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 outcomes

  1. immune biomarkers of sustained and prolonged response to treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty Peris, Prof

CONTACT

[email protected]

+390630155284

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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