Service de Dermatologie- Hopital Saint Joseph
Paris, 75014, France
NCT Number: NCT05938361
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Global evaluation of psoriasis and specific evaluation by areas
DLQI questionnaire at each visit
Visual analogic scale at W16, W28, W52
Visual analogic scale at each visit
Time frame: Week 28
Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit)
Time frame: Each visit (Week16-Week 28-Week 52)
Percentage of response based on global assessment compared to Baseline visit
Time frame: Week 16, week 28 and week 52
Percentage of response based on specific assessment by area compared to Baseline Visit
Time frame: From baseline visit to Week 52
Describe adverse events throughout follow-up
Time frame: Each visit (Baseline,Week 16, Week 28, Week 52)
Variation in visual analogic scale (VAS) value
Time frame: Each visit (Baseline, Week16, Week 28, Week 52)
Dermatology Life Quality Index (DLQI) score compared to Baseline Visit
Time frame: Each follow-up visit (Week 16, Week 28, Week 52)
Variation in visual analogic scale (VAS) value
Clin4all
Network
Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis - ZODIPSO Study
Acronym: ZODIPSO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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