Evaluating Tildrakizumab for Genital Psoriasis Treatment
Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic
This study is testing if a new medication called tildrakizumab can help people with genital psoriasis feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Almirall, S.A. Industry-sponsored |
| Drugs / interventions | Tildrakizumab |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT06029257 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of tildrakizumab in alleviating symptoms of genital psoriasis. Participants will receive tildrakizumab according to the summary of product characteristics, and their treatment outcomes will be evaluated through various quality of life scales. The study focuses on patients with significant genital involvement of psoriasis who require systemic biologic therapy. Data will be collected to determine the overall treatment safety and impact on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 with a confirmed diagnosis of psoriasis affecting the genital area and a need for systemic biologic therapy.
Not a fit: Patients who have recently been exposed to experimental treatments or those unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from genital psoriasis.
How similar studies have performed: Other studies have shown promising results with similar biologic therapies for psoriasis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Graz, Styria
- Medizinische Universität Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Senior Director Regional Medical Affairs
- Email: medicalat@almirall.com
- Phone: +43 0 15953960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.