Analyzing immune cells in psoriasis skin during IL-23 therapy
Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
This study is looking at skin samples from psoriasis patients who are not responding well to IL-23 therapy to see what immune cells might be causing their symptoms to come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06792487 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with moderate to severe psoriasis who are undergoing treatment with an anti-interleukin 23 (IL-23) biologic drug. The aim is to analyze skin biopsies from areas of the skin that are resistant to treatment or have flared up during therapy. By examining the immune infiltrate in these resistant plaques, the study seeks to identify the cellular sources of key cytokines that may contribute to disease recurrence. This research could provide insights into the mechanisms behind treatment resistance in psoriasis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with moderate to severe psoriasis who have been on anti-IL-23 therapy for at least six months and have experienced treatment-resistant lesions or flare-ups.
Not a fit: Patients who have achieved a complete response to anti-IL-23 therapy without any resistant plaques or flare-ups will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of psoriasis, particularly for patients experiencing treatment resistance.
How similar studies have performed: While studies on IL-23 blockade have shown effectiveness, this specific approach of analyzing immune infiltrates in resistant psoriasis lesions is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * moderate-severe psoriasis PASI\>10 * anti IL 23 biologic therapy for at least 6 months (for the group under treatment) * during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment) * patients able to express informed consent Exclusion Criteria: * patients unable to express informed consent * patients with complete response to anti IL23, without resistant plaques or disease flare-ups
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Ketty Peris, Prof — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Ketty Peris, Prof
- Email: ketty.peris@policlinicogemelli.it
- Phone: +390630155284
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.