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

Recruiting now

Conditions studied: Genital Psoriasis

In brief

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.

Key facts

Study ID

NCT06029257

Run by

Almirall, S.A.

People needed

110

Starts

2023-11-14

Expected to finish

2026-03-01

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Medizinische Universität Graz — Graz, Styria, Austria (enrolling)

Full record on ClinicalTrials.gov

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