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)

M-14745-42

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).

2019-12-17

2021-11-15

2021-11-15

Completed

Early phase I

178

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 178, 'type': 'ACTUAL'}}

2023-03-03