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)

Almirall

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Tildrakizumab 100 mg Solution for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04229836

M-14745-42

Details and patient eligibility

About

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).

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Tildrakizumab

Experimental group

Description:

Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).

Treatment:

Drug: Tildrakizumab 100 mg Solution for Injection