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

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Tildrakizumab

• Registration Number: NCT06030076
• Lead Sponsor: Almirall, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study Start: 2023-09-06
• Study First Posted: 2023-09-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tildrakizumab	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.

Primary Outcome Measures

Name	Time	Method
Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score	Baseline, Week 28	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.
World Health Organisation Well-Being Index (WHO-5) Score	Baseline up to Week 28	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab	At Baseline
Change from Baseline in Physician's Global Assessment (PGA) Score	Baseline, Week 4, 16 and 28	The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.
Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score	Baseline, Week 4, 16 and 28	The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.
Change from Baseline in Dermatology Life Quality Index (DLQI) Score	Baseline, Week 4, 16 and 28	The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.

Trial Locations

Locations (1)

Gesundheitszentrum Citypark Graz; 🇦🇹 Graz, Styria, Austria