Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis

Launched by CLIN4ALL · Jul 3, 2023

Keywords

ClinConnect Summary

The ZODIPSO study is researching the effectiveness and safety of a medication called Tildrakizumab in treating psoriasis in hard-to-reach areas like the scalp, nails, genital region, and palms and soles of the feet. Psoriasis is a long-lasting skin condition that affects many people, and some areas can be particularly challenging to treat. This trial aims to see how well Tildrakizumab works in these specific areas over the course of a year.

To participate in this study, you need to be at least 18 years old and have been diagnosed with moderate to severe psoriasis for at least six months. You should also have psoriasis affecting one of the difficult areas mentioned. If you qualify, you can expect to receive Tildrakizumab and will be monitored for your response to the treatment. It’s important to know that certain health conditions and ongoing treatments may prevent you from joining the study, so discussing your eligibility with your doctor is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record,
• • 2. Disease diagnosis \> 6 months (regardless of severity at diagnosis)
• • 3. Involvement of at least one of the following areas: nails, scalp, genital, palmoplantar (non-pustular)
• • 4. Indication for treatment by IL-23 inhibitor. Tildrakizumab must be the selected IL-23 inhibitor therapy prior to enrolling the patient in the study. Patients who have previously received previous treatment by IL-23 inhibitors may be included.
• • 5. Patient 18 years of age or older at the inclusion visit
• • 6. French social security beneficiary
• Exclusion Criteria:
• • 1. Patient unable to comply with study requirements (i.e.complete study questionnaires)
• • 2. Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record.
• • 3. Patient included in an interventional clinical trial at inclusion.
• • 4. Vulnerable patient or patient under court protection
• • 5. Patients with known hypersensitivity to IL-23 inhibitors
• • 6. Patients with HIV or active HBV or HCV infection at the time of inclusion
• • 7. Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion
• • 8. Patient with any other serious active infection present at inclusion that contraindicates IL23 inhibitors use.
• • 9. Pregnant or lactating woman