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Recruiting NCT06029257

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

— Observational Genital Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tildrakizumab.
Who it may be relevant to
Registry conditions: Genital Psoriasis. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic

Overview

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.

Interventions

  • Drug Tildrakizumab
    As provided in real-world clinical practice.

Primary outcome measures

  • Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1) [Time frame: Baseline up to Week 52]
  • Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score [Time frame: Baseline up to Week 52]
Secondary outcome measures (7)
  • Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score [Time frame: Baseline, Week 4, 16, 28 and 52]
  • Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region [Time frame: Baseline, Week 4, 16, 28 and 52]
  • Change From Baseline in the Dermatological Life Quality Index (DLQI) Score [Time frame: Baseline, Week 4, 16, 28 and 52]
  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score [Time frame: At Week 28 and 52]
  • Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score [Time frame: Baseline, Week 28 and 52]
  • Change from Baseline in Physician's Global Assessment (PGA) Score [Time frame: Baseline, Week 4, 16, 28 and 52]
  • Change From Baseline in World Health Organisation - 5 Well-Being Index (WHO-5) Score [Time frame: Baseline, Week 28 and 52]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medizinische Universität Graz — Graz

Identifiers

NCT: NCT06029257 · CZATCH-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗