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NCT Number: NCT06610942

Characterization of the Fungal Immunopeptidome Involved in the Immunopathological Mechanisms of Psoriasis

Psoriasis is a chronic immune-mediated skin disorder characterized by inflammatory cutaneous plaques and, occasionally, arthritis, affecting 60 million adults and children worldwide. Although a variety of treatments have been developed aimed to relieve the associated symptoms, there is yet no permanent cure for psoriasis. TH17 type immunity, via the production of IL-17A and other pro-inflammatory cytokines, are considered to play a central role in the pathogenesis of this disease. Moreover, experimental evidence obtained in animal models, points to human mycobiota as a trigger for the initiation and/or progression of psoriasis. Therefore, human studies are required to better characterize the major fungi implicated in the local and systemic inflammatory responses, as well as to determine the immunopeptidome that shapes the pathogenic T cell receptor repertoire.

We will explore the hypothesis that commensal fungi could participate in the chronic inflammatory immune response underlying the pathogenesis of human psoriasis via the recognition of cutaneous fungal antigens and/or via a gut-skin mycobiome cross-reactive mechanism

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Parasitologie-Mycologie Hôpital St Antoine

Paris, 75012, France

About this study

The overall aim of the project is :

i) to characterize the nature of human local and systemic inflammatory responses against commensal skin and gut fungal species in psoriatic patients (PsoP) and ii) to determine the fungal immunopeptidome that contributes to the shaping of the T cell receptor (TCR) repertoire of skin-infiltrating T cells. The project is divided into four major scientific objectives:

  • To determine the mycobiome profiles in healthy donors (HD) and PsoP.
  • To characterize the contribution of mycobiota to the local cutaneous CD4+ T cell response.
  • To assess systemic the CD4+ T cell-fungal cross-reactivity.
  • To establish the immunopeptidome of the major CD4+ T cell-reactive fungus enabling the development of an innovative immunotherapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adults with psoriasis failing local treatment. Adults requiring reconstructive plastic surgery (resident skin immunology checks).

Adults living in the same household as a patient suffering from psoriasis (intestinal mycobiome checks).

Exclusion criteria

Minors Individuals under legal protection. Pregnant or breastfeeding women

Treatment and study plan

Primary outcomes

  1. Determining the commensal fungi responsible for the immunopathological response in psoriasis.

    Time frame: 2 years

    Flow cytometry analysis of cytokine secretion profile in healthy and diseased subjects

Secondary outcomes

  1. Identification of peptides responsible for the immunopathological response in psoriasis.

    Time frame: 2 years

    LC-MS/MS analysis of MHC I and II peptides

Study contacts

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

Alicia MORENO

CONTACT

[email protected]

Alicia MORENO, Doctor

CONTACT

[email protected]

+33 149282000

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PSOFUNGI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Aug 26, 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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