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

Almirall

Status: Enrolling

Conditions: Genital Psoriasis

Treatments: Drug: Tildrakizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06029257

CZATCH-2023

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

110 participants in 1 patient group

Tildrakizumab

Description:

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.

Treatment:

Drug: Tildrakizumab