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

NCT05111210 | Recruiting

• 1 other identifier: 2020-076
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Psoriasis

Keywords

psoriasis; anti-IL-23 therapy; immune responses

Outcome Measures

Primary Outcomes (3)

• 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

  7 years

• Single cell transcriptome analysis

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

  7 years

• 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.

  7 years

Secondary Outcomes (2)

• Definition of an immune response signature

  7 years

• Identification of epigenetic modifications in cell populations in the skin and/or in circulating immune cells by anti-IL-23 therapy

  7 years

Study Arms (2)

Gp 1: 10 patients with cutaneous psoriasis

Visits for research are done as part of the care, no visits are added. There is only 1 visit for patients of this group, they will be sampled once with 51 mL of blood before initiation of a biotherapy and some data will be collected

Other: Blood sample; Other: Data collection

Gp 2: 80 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic

Visits for research are done as part of the care, no visits are added. Two visits are planned for this group of patients : before and after initiation of therapy. These patients will be sampled twice with 51 mL of blood. Skin biopsies will be obtained from a subset of 30 patients to analyse the skin transcriptome, before and after treatment with anti-IL-23 biologics Data will be collected at the two timepoints.

Other: Blood sample; Other: Data collection; Other: skin biopsies

Interventions

Blood sample OTHER

Blood will be collected in tubes heparinés BD (Vacutainer), homogenised, and immediately transported at room temperature to Institut Pasteur to be further processed

Gp 1: 10 patients with cutaneous psoriasis; Gp 2: 80 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic

Data collection OTHER

collection of socio-demographic, clinical and biological data.

Gp 1: 10 patients with cutaneous psoriasis; Gp 2: 80 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic

skin biopsies OTHER

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

Gp 2: 80 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• All patients:
• 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
• Patients require systemic treatment for psoriasis
• Patients are naïve to biological therapies
• Only for patients of Group 2:
• Patients requiring treatment with anti-IL-23 biologics (guselkumab, risankizumab, tildrakizumab) upon referent physician's decision.
• Patients are naïve to biological therapies or have received only one biologic, with a "wash-out" period of at least 4 months
• For all :
• Patient is minor
• Patient is pregnant or breastfeeding
• Patient is immunocompromised
• Patient is under legal protection, curatorship, guardianship

Sponsors & Collaborators

• Institut Pasteur: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

Lars ROGGE

Paris, Île-de-France Region, 75015, France

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lars Rogge

CONTACT

+33140613822; lars.rogge@pasteur.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

FR (1)