NCT06610942

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

September 20, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

FungiimmunopeptidomepsoriasisIL17

Outcome Measures

Primary Outcomes (1)

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

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

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (3)

Adult patients with psoriasis who have failed local treatment

"Healthy" controls (skin)

"Healthy" controls (stools)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with psoriasis failing local treatment. Studying various biological samples from these patients (skin, blood, stools, and skin swabs) will allow the investigation of the local and systemic immune response and an attempt to understand the involvement of the skin and intestinal mycobiome. Healthy controls (skin): Adult patients undergoing reconstructive surgery where healthy skin is removed. Studying samples of healthy skin will enable the investigation of the skin immune response in subjects without skin disease or autoimmune disease. Healt controls (stools): Living in the same household as the patient with psoriasis. This population will allow the study of the intestinal mycobiome in controls with environments and diets similar to those of patients with psoriasis. Healthy controls (blood): Blood samples from donors obtained from the French Blood Establishment (EFS). These samples will allow the study of the systemic immune response to better understand the

You may qualify if:

  • 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).

You may not qualify if:

  • Minors Individuals under legal protection. Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Parasitologie-Mycologie Hôpital St Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Alicia MORENO, Doctor

CONTACT

Alicia MORENO

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations