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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 22
- 主要终点
- Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tildrakizumab
Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).
干预措施: Tildrakizumab 100 mg Solution for Injection (Drug)
结局指标
主要结局
Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
时间窗: Week 24
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
时间窗: Baseline (Day 1) and Week 24
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
时间窗: Week 24
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
时间窗: Baseline (Day 1) and Week 24
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.
次要结局
- Change from Baseline in the Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score(Baseline (Day 1), Week 4, 16, 24)
- Absolute Psoriasis Area and Severity Index (PASI) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score(Baseline (Day 1), Week 4, 16, 24)
- Absolute Physician Global Assessment (PGA) Score(Baseline (Day 1), Week 4, 16, 24)
- Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1 with At Least a 2-Grade Reduction from Baseline(Baseline (Day 1), Week 4, 16, 24)
- Absolute Pain-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Skindex-16 Questionnaire Score at Week 24(Baseline (Day 1) and Week 24)
- Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24(Baseline (Day 1) and Week 24)
- Change from Baseline in the Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24(Baseline (Day 1) and Week 24)
- Percentage of Participants Achieving Absolute Dermatology Life Quality Index (DLQI) Scores Between 0-1 at Week 24(Week 24)
- Percentage of Participants Achieving Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score Between 0-1 at Week 24.(Week 24)
- Absolute Dermatology Life Quality Index (DLQI) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score(Baseline (Day 1), Week 4, 16, 24)
- Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score(Baseline (Day 1), Week 4, 16, 24)
- Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Score of 5, 3, and 1(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Physician Global Assessment (PGA) Score(Baseline (Day 1), Week 4, 16, 24)
- Absolute Skindex-16 Questionnaire Score at Week 24(Week 24)
- Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24(Week 24)
- Absolute Body Surface Area (BSA) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Body Surface Area (BSA) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Pruritus-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Absolute Scaling-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Scaling-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24(Baseline (Day 1) and Week 24)
- Absolute Pruritus-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Change from Baseline in the Absolute Pain-Numerical Rating Scale (NRS) Score(Baseline (Day 1), Week 4, 16, 24)
- Percentage of Participants Achieving a Score Greater Than or Equal to (>=) 1 in the Absolute Patient Benefit Index (PBI) Score at Week 24.(Week 24)
- Change from Baseline in the Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24(Baseline (Day 1) and Week 24)
- Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 24(Week 24)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Baseline (Day 1) up to Week 28)
- Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24(Week 24)