NCT06029257Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 1 Sept 2023
- Start date
- 14 Nov 2023
- Primary completion date
- Mar 2026
- Lead sponsor
- Almirall, S.A.
- Diseases
- Psoriasis
- NCT number
- NCT06029257
What you commit to
- Study type: Observational
- Planned participants: 110
- From 14 Nov 2023 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient exposed to any experimental treatment in the past 3 months prior to baseline.
- Previous treatment with Tildrakizumab.
Other illness
- Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
Other
- 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 dependent on the investigator, including but not restricted to employees of the study site.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.