A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

NCT ID: NCT06030076

Last Updated: 2025-01-29

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-06

Study Completion Date

2025-10-31

Brief Summary

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The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.

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 have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks.

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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Ilumetri®

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent.
2. \>=18 years of age.
3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
4. Switch to tildrakizumab due to:

1. primary or secondary treatment failure (PASI \>= 3 or ΔPASI \< 75 and/or DLQI \> 5)
2. adverse events, contraindication, intolerance
3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
5. Treatment with tildrakizumab planned in the frame of clinical practice.

Exclusion Criteria

1. 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.
2. \>=3 previous biologic treatments in the last 3 years.
3. Participation in a clinical trial simultaneous to participation in SW-ATCH.
4. Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
5. Patient dependent on the Investigator.
6. Previous treatment with Tildrakizumab.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gesundheitszentrum Citypark Graz

Graz, Styria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Senior Director Regional Medical Affairs

Role: CONTACT

+43 0 15953960

Other Identifiers

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SW-ATCH

Identifier Type: -

Identifier Source: org_study_id

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