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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
France
Lars ROGGE
RECRUITING
Paris
Contact Information
Primary
Lars Rogge
lars.rogge@pasteur.fr
+33140613822
Time Frame
Start Date: 2021-12-14
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 90
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Collaborators: Janssen Biotech, Inc.
Leads: Institut Pasteur

This content was sourced from clinicaltrials.gov