Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis (ZODIPSO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis of Scalp; Psoriasis Nail; Psoriasis Palmaris; Psoriasis Genital; Psoriasis Plantaris
• Intervention / Treatment: Other: Psoriasis clinical assessments; Other: Quality of life evaluation; Other: Satisfaction assessment; Other: Pruritus evaluation

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Mariem RAHO; Phone Number: +33663227688; Email: mariem.raho@clin4all.com

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Service de Dermatologie- Hopital Saint Joseph
    • Contact: ZARAA Dr Ines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single group; Cohort of patients with difficult-to-treat psoariasis locations on the nail, scalp, genital and/or palmoplantar area.	Other: Psoriasis clinical assessments; Global evaluation of psoriasis and specific evaluation by areas; Other: Quality of life evaluation; DLQI questionnaire at each visit; Other: Satisfaction assessment; Visual analogic scale at W16, W28, W52; Other: Pruritus evaluation; Visual analogic scale at each visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response to Tildrakizumab	Percentage of response based on global assessment compared to Baseline visit	Each visit (Week16-Week 28-Week 52)
Specific response to Tildrakizumab	Percentage of response based on specific assessment by area compared to Baseline Visit	Week 16, week 28 and week 52
Adverse events	Describe adverse events throughout follow-up	From baseline visit to Week 52
Evaluation of pruritus under treatment	Variation in visual analogic scale (VAS) value	Each visit (Baseline,Week 16, Week 28, Week 52)
Evaluation of quality of life under treatement	Dermatology Life Quality Index (DLQI) score compared to Baseline Visit	Each visit (Baseline, Week16, Week 28, Week 52)
Evaluation of satisfaction under treatement	Variation in visual analogic scale (VAS) value	Each follow-up visit (Week 16, Week 28, Week 52)

Collaborators and Investigators

• Sponsor: Clin4all
• Investigators: Principal Investigator: Ines ZARAA, MD, Saint Joseph Hospital Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; tildrakizumab; difficult-to-treat areas
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2022-A02735-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No