Exploration of the Cellular and Molecular Mechanisms in Patients Receiving Biotherapies Targeting the IL-23/IL-17 Axis in Cutaneous Psoriasis

ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Pasteur

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Other intervention

    Blood 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 intervention

    collection of socio-demographic, clinical and biological data.

  • skin biopsies

    Other intervention

    skin biopsies of 4 mm in diameter. These samples will not be taken on the face or in an area of skin folds

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Gp 1: 10 patients with cutaneous psoriasis2 interventions
Group B: Gp 2: 80 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
7 years
2

Single cell transcriptome analysis

Single cell transcriptome analysis of skin biopsies from patients with cutaneous psoriasis, before and after anti-IL-23 therapy.

Time frame
7 years
3

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.

Time frame
7 years

Secondary outcomes

1

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.

Time frame
7 years
2

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.

Time frame
7 years

Other outcomes

Sponsors and contacts

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Institut Pasteur

Lead sponsor

Janssen Biotech, Inc.

Collaborator