Evaluating Tildrakizumab for Genital Psoriasis Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medizinische Universität Graz
  Graz, Styria, Austria Recruiting

Study contacts

• Study coordinator: Senior Director Regional Medical Affairs
• Email: medicalat@almirall.com
• Phone: +43 0 15953960

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tildrakizumab for symptoms and quality of life in Canadians with moderate-to-severe plaque psoriasis (Fitzpatrick III+)

  This study will test how tildrakizumab affects symptoms, safety, and quality of life in adults in Canada with moderate-to-severe plaque psoriasis who are starting treatment through the ILUMYA SUPPORT® Program and have Fitzpatrick skin types III or higher.

  Recruiting at 7 sites Chronicle Academy · Burlington, Ontario and 6 other locations · NCT07370766

• Switching to Tildrakizumab for Moderate to Severe Plaque Psoriasis

  This study tests if switching patients with moderate to severe plaque psoriasis to a new medication called tildrakizumab can improve their skin condition and quality of life.

  Recruiting Almirall, S.A. · Graz, Styria · NCT06030076

• Assessing immune response in psoriasis patients treated with Tildrakizumab

  This study tests how the medication Tildrakizumab affects the immune system in people with moderate to severe psoriasis by looking at their skin and blood before and after treatment.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT05390515

• Assessing pregnancy outcomes in women treated with tildrakizumab

  This study is trying to see how pregnancy and baby outcomes are affected in women who took tildrakizumab compared to those who didn't.

  Recruiting Sun Pharmaceutical Industries Limited · San Diego, California · NCT03992729

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.