A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)

NCT06029257 | Recruiting

• 1 other identifier: CZATCH-2023
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.

Conditions

Genital Psoriasis

Keywords

Psoriasis; Plaque psoriasis; Skin Diseases; Tildrakizumab

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)

  The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.

  Baseline up to Week 52

• Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score

  mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved.

  Baseline up to Week 52

Secondary Outcomes (7)

• Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score

  Baseline, Week 4, 16, 28 and 52

• Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region

  Baseline, Week 4, 16, 28 and 52

• Change From Baseline in the Dermatological Life Quality Index (DLQI) Score

  Baseline, Week 4, 16, 28 and 52

• Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score

  At Week 28 and 52

• Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score

  Baseline, Week 28 and 52

Study Arms (1)

Tildrakizumab

Participants who have been prescribed tildrakizumab in the treatment of plaque psoriasis with a manifestation in the genital area according to SmPC in routine clinical practice settings will be observed prospectively for up to 52 weeks.

Drug: Tildrakizumab

Interventions

Tildrakizumab DRUG

As provided in real-world clinical practice.

Also known as: Ilumetri®

Tildrakizumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female psoriasis participants with genital symptoms will be observed in this study.

You may qualify if:

• Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (\>=) 3.
• Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
• Age 18 - 99 years.
• Informed consent in writing in accordance with applicable country regulations
• Patient must have plaque psoriasis affecting a body surface area (BSA) \>= 1% in a non-genital area at baseline.
• Patient willing and able to fill out study questionnaires.

You may not qualify if:

• Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the investigator, should not participate in the study.
• Patient exposed to any experimental treatment in the past 3 months prior to baseline.
• Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
• Patient dependent on the investigator, including but not restricted to employees of the study site.
• Previous treatment with Tildrakizumab.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Medizinische Universität Graz

Graz, Styria, 8020, Austria

RECRUITING

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

tildrakizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Central Study Contacts

Senior Director Regional Medical Affairs

CONTACT

+43 0 15953960; medicalat@almirall.com

Study Design

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

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: November 14, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)