Assessing patient wellbeing with Tildrakizumab for plaque psoriasis
Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version
This study looks at how well Tildrakizumab helps people with moderate to severe plaque psoriasis feel in their everyday lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Almirall, S.A. Industry-sponsored |
| Drugs / interventions | Tildrakizumab |
| Locations | 4 sites (Ostrava and 3 other locations) |
| Trial ID | NCT06488170 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between clinical symptoms and quality of life in patients receiving Tildrakizumab for moderate to severe plaque psoriasis. Participants will be monitored in a live clinical setting to gather patient-reported outcomes related to their wellbeing. The study focuses on individuals who are already prescribed Tildrakizumab as part of their treatment plan, ensuring that data reflects real-world experiences. The findings may help to better understand the impact of this therapy on patients' daily lives.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with moderate to severe chronic plaque psoriasis who are eligible for systemic biologic therapy.
Not a fit: Patients who have contraindications to Tildrakizumab or those currently participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how Tildrakizumab improves quality of life for patients with plaque psoriasis.
How similar studies have performed: While this approach is observational, similar studies assessing patient-reported outcomes in psoriasis have shown promising results in understanding treatment impacts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart. * Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study. * Participant aged greater than or equal to (\>=) 18 years at Inclusion. * Written informed consent. Exclusion Criteria: * Participant unable or unwilling to comply with the requirements of the study. * Participant who should not participate in the study for any reason at the discretion of the treating physician. * Participants participating in a simultaneous clinical trial. * Any contraindication against the use of Tildrakizumab according to the SmPC. * Exposure to \>= 3 biologics prior to inclusion. * Participant dependent on the investigator, e.g. as employee
Where this trial is running
Ostrava and 3 other locations
- University Hospital Ostrava — Ostrava, Czechia (Recruiting)
- Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše — Pilsen, Czechia (Recruiting)
- University Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)
- University Hospital in Motol — Praha, Czechia (Recruiting)
Study contacts
- Study coordinator: Kveta Vrablikova
- Email: kveta.vrablikova@almiral.com
- Phone: +420 734 522 991
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.