A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting

NCT ID: NCT06488170

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2026-01-31

Brief Summary

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The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tildrakizumab

Participants who received Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the SmPC will be observed for Week 28.

Tildrakizumab

Intervention Type DRUG

As provided in real world clinical practice.

Interventions

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Tildrakizumab

As provided in real world clinical practice.

Intervention Type DRUG

Other Intervention Names

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IL-23p19 inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

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University Hospital Ostrava

Ostrava, , Czechia

Site Status

Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše

Pilsen, , Czechia

Site Status

University Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

University Hospital in Motol

Prague, , Czechia

Site Status

General university hospital Prague

Prague, , Czechia

Site Status

University Hospital Bulovka

Prague, , Czechia

Site Status

Masarykova hospital Ústí nad Labem

Ústí nad Labem, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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POSITIVE LIGHT

Identifier Type: -

Identifier Source: org_study_id

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