About this trial
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a monocentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in psoriasis patients attending the dermatology department of hospital Cochin (APHP).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (>18 years)
Presenting with cutaneous psoriasis
Patients have signed an informed consent
Beneficiary of the health insurance, except for the AME Only for patients of Group 1
Disqualifiers
None
Trial population
The study population to be included are patients affected by cutaneous psoriasis, requiring systemic biological treatment and attended to in the Dermatology Department of the Cochin Hospital. Patients will be divided into two groups: Group 1 patients will participate once before initiation of therapy, Group 2 will participate before and after initiation of anti-IL-23 biologic treatment.
Trial design
Case-control
Prospective
Treatments tested in this trial
Blood sample
Other interventionBlood will be collected in tubes heparinés BD (Vacutainer), homogenised, and immediately transported at room temperature to Institut Pasteur to be further processed
Data collection
Other interventioncollection of socio-demographic, clinical and biological data.
skin biopsies
Other interventionskin biopsies of 4 mm in diameter. These samples will not be taken on the face or in an area of skin folds
Treatment groups
Trial outcomes
Primary outcomes
Profiling of open chromatin regions
Profiling of open chromatin regions (ATAC seq), of the transcriptome (RNA-seq), of the genome (genotyping), and of cytokine expression (Luminex technology) in T lymphocytes from patients with cutaneous psoriasis, untreated or treated with IL-23 in vitro
Single cell transcriptome analysis
Single cell transcriptome analysis of skin biopsies from patients with cutaneous psoriasis, before and after anti-IL-23 therapy.
Analysis of the frequencies of MAIT, iNKT, γδ TCR+, CD4+ et CD8+ T cells
Analysis of the frequencies of MAIT, iNKT, γδ TCR+, CD4+ et CD8+ T cells in the peripheral blood of patients with cutaneous psoriasis, before and after initiation of anti-IL-23 treatment to analyse the effect of anti-IL-23 therapy on the immune responses.
Secondary outcomes
Definition of an immune response signature
immune response signature :gene expression, protein secretion or immune cell frequencies that correlates with therapeutic response to anti-IL-23 therapy in cutaneous psoriasis patients.
Identification of epigenetic modifications in cell populations in the skin and/or in circulating immune cells by anti-IL-23 therapy
analyzis of the effects of IL-23 inhibitors on gene expression in specific cell populations isolated from peripheral blood. Particular focis on CD4+ and CD8+ T cells, as well as monocytes.
Sponsors and contacts
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Institut Pasteur
Lead sponsor
Janssen Biotech, Inc.
Collaborator