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A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO) | Clinical Trials | Clareo Health

RECRUITING

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

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

NCT06029257•Almirall, S.A.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Medizinische Universität Graz

Graz, Styria, Austria

Key Dates

Start Date

November 14, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

January 29, 2025

Enrollment

110

ESTIMATED participants

Conditions

Genital Psoriasis

Interventions

Tildrakizumab

DRUG

Contacts

Senior Director Regional Medical Affairs

CONTACT

+43 0 15953960 medicalat@almirall.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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