NCT05938361

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Clin4all · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Psoriasis Palmaris
• Psoriasis Genital
• Psoriasis of Scalp
• Psoriasis Plantaris
• Psoriasis Nail

Interventions

Type	Name	Description
OTHER	Psoriasis clinical assessments	Global evaluation of psoriasis and specific evaluation by areas
OTHER	Quality of life evaluation	DLQI questionnaire at each visit
OTHER	Satisfaction assessment	Visual analogic scale at W16, W28, W52
OTHER	Pruritus evaluation	Visual analogic scale at each visit

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-11-01
• Completion: 2025-10-15
• First posted: 2023-07-10
• Last updated: 2025-09-24

Locations

1 site across 1 country: France