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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-14

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Genital Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tildrakizumab

Intervention Type DRUG

As provided in real-world clinical practice.

Interventions

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Tildrakizumab

As provided in real-world clinical practice.

Intervention Type DRUG

Other Intervention Names

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Ilumetri®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No