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

Psoriasis of Scalp Clinical Trial

— ZODIPSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938361
• Other study ID #: 2022-A02735-38
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: July 2023
• Source: Clin4all
• Contact: Mariem RAHO
• Phone: +33663227688
• Email: mariem.raho[@]clin4all.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Genital
• Psoriasis Nail
• Psoriasis of Scalp
• Psoriasis Palmaris

Intervention

Other:
• Psoriasis clinical assessments
Global evaluation of psoriasis and specific evaluation by areas
• Quality of life evaluation
DLQI questionnaire at each visit
• Satisfaction assessment
Visual analogic scale at W16, W28, W52
• Pruritus evaluation
Visual analogic scale at each visit

Locations

Country	Name	City	State
France	Service de Dermatologie- Hopital Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clin4all

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response to Tildrakizumab	Percentage of response based on global assessment compared to Baseline visit	Each visit (Week16-Week 28-Week 52)
Secondary	Specific response to Tildrakizumab	Percentage of response based on specific assessment by area compared to Baseline Visit	Week 16, week 28 and week 52
Secondary	Adverse events	Describe adverse events throughout follow-up	From baseline visit to Week 52
Secondary	Evaluation of pruritus under treatment	Variation in visual analogic scale (VAS) value	Each visit (Baseline,Week 16, Week 28, Week 52)
Secondary	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)
Secondary	Evaluation of satisfaction under treatement	Variation in visual analogic scale (VAS) value	Each follow-up visit (Week 16, Week 28, Week 52)