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NCT Number: NCT05938361

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Dermatologie- Hopital Saint Joseph

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patient included in an interventional clinical trial at inclusion.
  • Vulnerable patient or patient under court protection
  • Patients with known hypersensitivity to IL-23 inhibitors
  • Patients with HIV or active HBV or HCV infection at the time of inclusion
  • Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion
  • Patient with any other serious active infection present at inclusion that contraindicates IL23 inhibitors use.
  • Pregnant or lactating woman

Treatment and study plan

Psoriasis clinical assessments

Other

Global evaluation of psoriasis and specific evaluation by areas

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

Primary outcomes

  1. Specific response to Tildrakizumab at W28

    Time frame: Week 28

    Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit)

Secondary outcomes

  1. Overall response to Tildrakizumab

    Time frame: Each visit (Week16-Week 28-Week 52)

    Percentage of response based on global assessment compared to Baseline visit

  2. Specific response to Tildrakizumab

    Time frame: Week 16, week 28 and week 52

    Percentage of response based on specific assessment by area compared to Baseline Visit

  3. Adverse events

    Time frame: From baseline visit to Week 52

    Describe adverse events throughout follow-up

  4. Evaluation of pruritus under treatment

    Time frame: Each visit (Baseline,Week 16, Week 28, Week 52)

    Variation in visual analogic scale (VAS) value

  5. Evaluation of quality of life under treatement

    Time frame: Each visit (Baseline, Week16, Week 28, Week 52)

    Dermatology Life Quality Index (DLQI) score compared to Baseline Visit

  6. Evaluation of satisfaction under treatement

    Time frame: Each follow-up visit (Week 16, Week 28, Week 52)

    Variation in visual analogic scale (VAS) value

Sponsors and collaborators

Lead sponsor

Clin4all

Network

Registry information

Official study title

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

Acronym: ZODIPSO

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 10, 2023
Registry last updated
Sep 24, 2025

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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