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

NCT05938361 | Active Not Recruiting

• 1 other identifier: 2022-A02735-38
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Palmaris; Psoriasis Genital; Psoriasis of Scalp; Psoriasis Plantaris; Psoriasis Nail

Keywords

Psoriasis; tildrakizumab; difficult-to-treat areas

Outcome Measures

Primary Outcomes (1)

• Specific response to Tildrakizumab at W28

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

  Week 28

Secondary Outcomes (6)

• Overall response to Tildrakizumab

  Each visit (Week16-Week 28-Week 52)

• Specific response to Tildrakizumab

  Week 16, week 28 and week 52

• Adverse events

  From baseline visit to Week 52

• Evaluation of pruritus under treatment

  Each visit (Baseline,Week 16, Week 28, Week 52)

• Evaluation of quality of life under treatement

  Each visit (Baseline, Week16, Week 28, Week 52)

Study Arms (1)

Single group

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

Other: Psoriasis clinical assessments; Other: Quality of life evaluation; Other: Satisfaction assessment; Other: Pruritus evaluation

Interventions

Psoriasis clinical assessments OTHER

Global evaluation of psoriasis and specific evaluation by areas

Single group

Quality of life evaluation OTHER

DLQI questionnaire at each visit

Single group

Satisfaction assessment OTHER

Visual analogic scale at W16, W28, W52

Single group

Pruritus evaluation OTHER

Visual analogic scale at each visit

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of moderate to severe chronic plaque psoriasis with specific difficult-to-treat locations.

You may qualify if:

• 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.
• French social security beneficiary

You may not qualify if:

• 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.
• Vulnerable patient or patient under court protection
• Patients with known hypersensitivity to IL-23 inhibitors
• Pregnant or lactating woman

Sponsors & Collaborators

• Clin4all: lead

Study Sites (1)

Service de Dermatologie- Hopital Saint Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ines ZARAA, MD

  Saint Joseph hospital Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 10, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: October 15, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)