Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

An International, Multicentre, Open- Label, Interventional Phase IV Clinical Study to Investigate the Efficacy and Safety of Tildrakizumab 100 mg in Patients With Moderate- Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

The main aim of the study is to evaluate the efficacy, safety and impact on the health-related quality of life (HRQoL) in participants with moderate-to-severe chronic plaque psoriasis who are treated with tildrakizumab 100 milligrams (mg).

Inclusion Criteria:

• Provide signed written and dated informed consent given before any study related activity is performed
• Participants with a diagnosis of moderate to severe plaque psoriasis
• Participants eligible for systemic biologic treatment as assessed by the investigator or having had a primary/secondary failure to treatment with one or more anti-Tumor Necrosis Factor (TNF) biologic agents for psoriasis

Exclusion Criteria:

• Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
• Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®
• Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
• Other forms of psoriasis than chronic plaque-type
• Current severe and/or uncontrolled psoriatic arthritis (PsA), or participants with PsA that is currently receiving systemic treatment
• Drug-induced psoriasis at the Screening Visit
• Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
• Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit
• Active infection disease or history of recurrent infection
• Active or latent tuberculosis (TB) at Screening visit
• Positive test for human immunodeficiency virus or any other immunosuppressive disease
• Participants with exposure to psoriasis systemic investigational drugs in the previous year
• Live vaccination within 4 weeks prior to the Baseline Visit
• Participants who intend to use any concomitant medication with immunomodulating or systemic corticosteroids