Understanding how anti-IL-23 therapies work in psoriasis patients
Exploration of the Cellular and Molecular Mechanisms in Patients Receiving Biotherapies Targeting the IL-23/IL-17 Axis in Cutaneous Psoriasis
This study is trying to understand how a new psoriasis treatment works by looking at blood and skin samples from patients before and after they start the therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur Industry-sponsored |
| Drugs / interventions | guselkumab, risankizumab, tildrakizumab |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT05111210 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the cellular and molecular mechanisms involved in the response to anti-IL-23 biologics in patients with cutaneous psoriasis. It will involve two groups of patients: one group will be assessed before starting therapy, while the other will be evaluated both before and after treatment. The study will analyze gene expression and immune responses in blood samples and skin biopsies to better understand the IL-23/IL-17 axis's role in psoriasis. The findings could help identify why some patients do not respond to these therapies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with cutaneous psoriasis who require systemic biological treatment and are naïve to biological therapies.
Not a fit: Patients who are minors, pregnant, breastfeeding, immunocompromised, or unable to comply with study requirements will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for psoriasis patients by enhancing understanding of therapy responses.
How similar studies have performed: Other studies exploring the IL-23/IL-17 axis have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full 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
Where this trial is running
Paris, Île-de-France Region
- Lars ROGGE — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Lars Rogge
- Email: lars.rogge@pasteur.fr
- Phone: +33140613822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.