Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
- - 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.
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
- - Group 2: 40 patients with a medical decision to treat cutaneous psoriasis with an anti-IL-23 biologic.
: 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.
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.