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

Last updated: September 19, 2025
Sponsor: Clin4all
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Skin Wounds

Rosacea

Rash

Treatment

Psoriasis clinical assessments

Pruritus evaluation

Quality of life evaluation

Clinical Study ID

NCT05938361
2022-A02735-38
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documentedin 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 selectedIL-23 inhibitor therapy prior to enrolling the patient in the study. Patients whohave 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

Exclusion

Exclusion Criteria:

  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 thestudy. 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 atinclusion

  8. Patient with any other serious active infection present at inclusion thatcontraindicates IL23 inhibitors use.

  9. Pregnant or lactating woman

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Psoriasis clinical assessments
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
October 15, 2025

Study 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.

Connect with a study center

  • Service de Dermatologie- Hopital Saint Joseph

    Paris, 75014
    France

    Site Not Available

  • Service de Dermatologie- Hopital Saint Joseph

    Paris 2988507, 75014
    France

    Site Not Available

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