RecruitingNCT05111210

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


Sponsor

Institut Pasteur

Enrollment

90 participants

Start Date

Dec 14, 2021

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria23

  • 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
  • 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

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Interventions

OTHERBlood sample

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

OTHERData collection

collection of socio-demographic, clinical and biological data.

OTHERskin biopsies

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


Locations(1)

Lars ROGGE

Paris, Île-de-France Region, France

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NCT05111210


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