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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.
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. They are reported at least once during the course of psoriatic disease in more than 80%, 50%, 60%, 12% of patients, respectively.
Despite recent progress in the management of the disease, these localizations remain a challenge for psoriasis patients because of their impact on quality of life and the difficulty of treating them.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has already demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis in two international multicenter randomized clinical trials : reSURFACE 1 and reSURFACE 2. However, real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Cohort of patients with difficult-to-treat psoariasis locations on the nail, scalp, genital and/or palmoplantar area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psoriasis clinical assessments | Other | Global evaluation of psoriasis and specific evaluation by areas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specific response to Tildrakizumab at W28 | Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit) | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response to Tildrakizumab | Percentage of response based on global assessment compared to Baseline visit | Each visit (Week16-Week 28-Week 52) |
| Specific response to Tildrakizumab | Percentage of response based on specific assessment by area compared to Baseline Visit |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of moderate to severe chronic plaque psoriasis with specific difficult-to-treat locations.
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| Name | Affiliation | Role |
|---|---|---|
| Ines ZARAA, MD | Saint Joseph hospital Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Dermatologie- Hopital Saint Joseph | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Quality of life evaluation | Other | DLQI questionnaire at each visit |
|
| Satisfaction assessment | Other | Visual analogic scale at W16, W28, W52 |
|
| Pruritus evaluation | Other | Visual analogic scale at each visit |
|
| Week 16, week 28 and week 52 |
| Adverse events | Describe adverse events throughout follow-up | From baseline visit to Week 52 |
| Evaluation of pruritus under treatment | Variation in visual analogic scale (VAS) value | Each visit (Baseline,Week 16, Week 28, Week 52) |
| Evaluation of quality of life under treatement | Dermatology Life Quality Index (DLQI) score compared to Baseline Visit | Each visit (Baseline, Week16, Week 28, Week 52) |
| Evaluation of satisfaction under treatement | Variation in visual analogic scale (VAS) value | Each follow-up visit (Week 16, Week 28, Week 52) |