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

NCT06030076 | Recruiting

• 1 other identifier: SW-ATCH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Tildrakizumab; Moderate-to-severe plaque psoriasis; Prospective

Outcome Measures

Primary Outcomes (2)

• Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score

  TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.

  Baseline, Week 28

• World Health Organisation Well-Being Index (WHO-5) Score

  The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

  Baseline up to Week 28

Secondary Outcomes (4)

• Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score

  Baseline, Week 4, 16 and 28

• Change from Baseline in Physician's Global Assessment (PGA) Score

  Baseline, Week 4, 16 and 28

• Change from Baseline in Dermatology Life Quality Index (DLQI) Score

  Baseline, Week 4, 16 and 28

• Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab

  At Baseline

Study Arms (1)

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.

Drug: Tildrakizumab

Interventions

Tildrakizumab DRUG

As provided in real-world clinical practice.

Also known as: Ilumetri®

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.

You may qualify if:

• Written informed consent.
• \>=18 years of age.
• Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
• Switch to tildrakizumab due to:
• primary or secondary treatment failure (PASI \>= 3 or ΔPASI \< 75 and/or DLQI \> 5)
• adverse events, contraindication, intolerance
• patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
• Treatment with tildrakizumab planned in the frame of clinical practice.

You may not qualify if:

• 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.
• \>=3 previous biologic treatments in the last 3 years.
• Participation in a clinical trial simultaneous to participation in SW-ATCH.
• 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.
• Previous treatment with Tildrakizumab.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Gesundheitszentrum Citypark Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

tildrakizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Senior Director Regional Medical Affairs

CONTACT

+43 0 15953960; medicalat@almirall.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: September 6, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)