Informations générales (source: ClinicalTrials.gov)
Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis - ZODIPSO Study (ZODIPSO)
Observational
Clin4all (Voir sur ClinicalTrials)
juin 2023
avril 2025
29 juin 2024
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French
population.Some specific localizations are more difficult to manage, such as the scalp,
nails, genital region and palmoplantar localizations.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has demonstrated
efficacy and safety in the treatment of patients with moderate to severe psoriasis.
Real-life data on the efficacy of Tildrakizumab in unselected patients with these
difficult-to-treat locations are still limited.
The aim of the ZODIPSO study is to evaluate the efficacy and safety of Tildrakizumab in
patients presented difficult to treat locations in psoriasis : nail, scalp, genital and
palmoplantar.
The main objective is to assess the overall response and the specific response to
Tildrakizumab at these specific areas up to W52.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | ZARAA Dr Ines | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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