Switching to Tildrakizumab for Moderate to Severe Plaque Psoriasis

A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence 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 in Austria and Switzerland

This study tests if switching patients with moderate to severe plaque psoriasis to a new medication called tildrakizumab can improve their skin condition and quality of life.

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: 1 site (Graz, Styria)
• Trial ID: NCT06030076 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of transitioning patients with moderate to severe plaque psoriasis from their current biologic treatment to tildrakizumab. It focuses on patient-reported outcomes, assessing changes in psoriasis intensity and quality of life before and after the switch. The study also explores the reasons behind patients' decisions to switch biologics, whether due to treatment failure, adverse events, or personal preferences.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older currently receiving biologic therapy for moderate to severe plaque psoriasis who are considering switching to tildrakizumab.

Not a fit: Patients who have had three or more previous biologic treatments in the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options and outcomes for patients with moderate to severe plaque psoriasis.

How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in improving patient outcomes with biologic treatments.

Eligibility criteria

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.

Where this trial is running

Graz, Styria

• Gesundheitszentrum Citypark Graz — Graz, Styria, Austria (Recruiting)

Study contacts

• Study coordinator: Senior Director Regional Medical Affairs

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