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

NCT ID: NCT05938361

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-10-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

Cohort of patients with difficult-to-treat psoariasis locations on the nail, scalp, genital and/or palmoplantar area.

Psoriasis clinical assessments

Intervention Type: OTHER

Global evaluation of psoriasis and specific evaluation by areas

Quality of life evaluation

Intervention Type: OTHER

DLQI questionnaire at each visit

Satisfaction assessment

Intervention Type: OTHER

Visual analogic scale at W16, W28, W52

Pruritus evaluation

Intervention Type: OTHER

Visual analogic scale at each visit

Interventions

Psoriasis clinical assessments

Global evaluation of psoriasis and specific evaluation by areas

Intervention Type: OTHER

Quality of life evaluation

DLQI questionnaire at each visit

Intervention Type: OTHER

Satisfaction assessment

Visual analogic scale at W16, W28, W52

Intervention Type: OTHER

Pruritus evaluation

Visual analogic scale at each visit

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in 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 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.

5. Patient 18 years of age or older at the inclusion visit

6. French social security beneficiary

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 the study. 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 at inclusion

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

9. Pregnant or lactating woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clin4all

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ines ZARAA, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph hospital Paris

Locations

Service de Dermatologie- Hopital Saint Joseph

Paris, , France

Countries

France

Other Identifiers

2022-A02735-38

Identifier Type: -

Identifier Source: org_study_id