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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.
Non

inclusion Criteria:

For all :
  • - Patient is minor.
  • - Patient is pregnant or breastfeeding.
  • - Patient is immunocompromised.
  • - Patient is under legal protection, curatorship, guardianship.
  • - Patient refuses consent.
  • - Patient is unable to comply with study requirements for geographic, social or psychiatric reason.
  • - Beneficiary of the AME Only for patients of Group 1.
  • - Patient has received biologics Only for patients of Group 2.
  • - Patient has a contraindication to the chosen biotherapy.
  • - Patient has received biologics within the last 4 months.
  • - Patient has been treated with 2 or more biologics.
- Patient has already received an anti-IL-23 biologic

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05111210
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut Pasteur
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

The aim of this project is to study the cellular and molecular mechanisms in patients receiving anti-IL-23 biologics as treatment for cutaneous psoriasis, in order to improve the understanding of the role of IL-23/IL-17 axis in this pathology. This objective is detailed in three specific aims:

  • - Define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes in patients with skin psoriasis and correlate it with the patient's genotype.
  • - Identify at the single cell level the cells expressing IL-23R and/or producing IL-17 in the skin of patients with skin psoriasis; - Characterize the in vivo effects of anti-IL-23 therapy on the immune responses of patients with skin psoriasis, by analysing gene expression and protein secretion in whole blood cultures before and after treatment; The secondary objective of this study is to identify mechanisms of non-response to anti-IL-23 therapy in cutaneous psoriasis patients.
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. Group 1: 10 patients with cutaneous psoriasis for the phenotypic and transcriptional analyses of T cell populations in peripheral blood. These patients will be sampled once before initiation of biotherapy.
  • - Group 2: 40 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic.
These patients will be sampled twice (before and after initiation of therapy), for the analysis of blood immune cell populations using spectral flow cytometry, and immune responses using whole blood cultures. Skin biopsies will be obtained from a subset of 10 patients to analyse the skin transcriptome, before and after treatment with anti-IL-23 biologics.

Arms & Interventions

Arms

: Group 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

: 40 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 10 patients to analyse the skin transcriptome, before and after treatment with anti-IL-23 biologics Data will be collected at the two timepoints.

Interventions

Other: - Blood sample

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

Other: - Data collection

collection of socio-demographic, clinical and biological data.

Other: - skin biopsies

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

Contact a Trial Team

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International Sites

Lars ROGGE, Paris, Ile De France, France

Status

Address

Lars ROGGE

Paris, Ile De France, 75015

Site Contact

Selim Aractangi, Pr

[email protected]

+33 1 58 41 18 13

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