Evaluating Tildrakizumab for hard-to-treat psoriasis areas

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

This study is testing if Tildrakizumab can help people with hard-to-treat psoriasis on areas like the scalp, nails, and palms feel better over a year.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Clin4all (Research network)
• Drugs / interventions: Tildrakizumab
• Locations: 1 site (Paris)
• Trial ID: NCT05938361 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficacy and safety of Tildrakizumab, an anti-IL-23 monoclonal antibody, in patients with moderate to severe psoriasis affecting difficult-to-treat areas such as the scalp, nails, genital region, and palms/soles. The study will involve clinical assessments, quality of life evaluations, and patient satisfaction surveys over a period of 52 weeks. By gathering real-life data, the study seeks to provide insights into the effectiveness of Tildrakizumab in these specific localizations, which are often challenging to manage. The findings could help improve treatment strategies for patients suffering from these localized forms of psoriasis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderate to severe chronic plaque psoriasis affecting the nails, scalp, genital region, or palms/soles.

Not a fit: Patients who do not have psoriasis or those with mild forms of the disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients with difficult-to-treat psoriasis areas, improving their quality of life.

How similar studies have performed: Previous studies have shown Tildrakizumab to be effective in treating moderate to severe psoriasis, but this specific focus on difficult-to-treat areas is less explored.

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

Where this trial is running

Paris

• Service de Dermatologie- Hopital Saint Joseph — Paris, France (Recruiting)

Study contacts

• Principal investigator: Ines ZARAA, MD — Saint Joseph hospital Paris
• Study coordinator: Mariem RAHO

Conditions Psoriasis Palmaris; Psoriasis Genital; Psoriasis of Scalp; Psoriasis Plantaris; Psoriasis Nail; Psoriasis; tildrakizumab; difficult-to-treat areas