PsoriasisPSOFUNGINCT06610942
Characterization of the Fungal Immunopeptidome Involved in the Immunopathological Mechanisms of Psoriasis
An observational study of Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Psoriasis is a chronic immune-mediated skin disorder characterized by inflammatory cutaneous plaques and, occasionally, arthritis, affecting 60 million adults and children worldwide. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Minors Individuals under legal protection. Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alicia MORENO contact
France1 site
Service de Parasitologie-Mycologie Hôpital St Antoine
Paris, 75012
About this study
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
Read the detailed description
The overall aim of the project is :
- 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.
- Conditions
- Psoriasis
- Keywords
- Fungi, immunopeptidome, psoriasis, IL17
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with psoriasis who have failed local treatment | Not described | |
| "Healthy" controls (skin) | Not described | |
| "Healthy" controls (stools) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the commensal fungi responsible for the immunopathological response in psoriasis.
Flow cytometry analysis of cytokine secretion profile in healthy and diseased subjects
Measured: 2 years
Secondary outcomes (1)
Identification of peptides responsible for the immunopathological response in psoriasis.
LC-MS/MS analysis of MHC I and II peptides
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610942
- Sponsor's protocol ID
- APHP240968
- Other IDs
- 2024-A01701-46
- Acronym
- PSOFUNGI
- Status last verified
- Aug 2025
- First submitted
- 20 Sep 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Fungal Immunopeptidome Involved in the Immunopathological Mechanisms of Psoriasis
- ClinicalTrials.gov ID
- NCT06610942
- Acronym / sponsor ID
- PSOFUNGI / APHP240968
- Conditions
- Psoriasis
- Keywords
- Fungi, immunopeptidome, psoriasis, IL17
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The overall aim of the project is :
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult patients with psoriasis who have failed local treatment | – | – |
| "Healthy" controls (skin) | – | – |
| "Healthy" controls (stools) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Minors Individuals under legal protection. Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Identification of peptides responsible for the immunopathological response in psoriasis.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia MORENO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia MORENO, Doctor (+33 149282000, alicia.moreno@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the commensal fungi responsible for the immunopathological response in psoriasis. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.