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)

• Status: Active, not recruiting
• Trial end date: 2021-11-02
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Almirall, S.A.
• Treatments: Antibodies, Monoclonal

Criteria

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