Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis (NCT05938361) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis
France120 participantsStarted 2023-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record,
✓. Disease diagnosis \> 6 months (regardless of severity at diagnosis)
✓. Involvement of at least one of the following areas: nails, scalp, genital, palmoplantar (non-pustular)
✓. 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.
✓. Patient 18 years of age or older at the inclusion visit
✓. French social security beneficiary
Exclusion criteria
✕. Patient unable to comply with study requirements (i.e.complete study questionnaires)
✕. Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record.