An Open-Label, Randomised, Phase IV Study, to Assess the Efficacy and Safety of Tildrakizumab in Patients With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (TRANSITION)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 3
- 主要终点
- Part 2: Percentage of Participants Achieving a Psoriasis Area Severity Index 75 (PASI 75) after Tildrakizumab Treatment at Week 40
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16. The study consists of two parts. Part 1 will include the first 16 weeks of the Treatment Period and Part 2 will include the last 24 weeks of the Treatment Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 at least 6 months history of chronic plaque psoriasis
- •Participants diagnosed with moderate-to-severe plaque psoriasis at the Screening Visit
- •Candidate for systemic treatment for plaque psoriasis at the Screening Visit
排除标准
- •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
- •Participants with drug-induced psoriasis at the Screening Visit
- •Participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis
- •Participants with history of hypersensitivity or allergy to the study drugs
- •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 infectious disease at the Screening Visit
- •Participants positive test for human immunodeficiency virus or any other immunosuppressive disease
- •Previous exposure to fumarate-based drug or a biologic systemic treatment
- •Live vaccination within 4 weeks prior to the Baseline Visit
- •Participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
- •Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
研究组 & 干预措施
Non-Germany: Dimethyl fumarate standard scheme
Part 1: Participants will receive Dimethyl fumarate (DMF) standard scheme from baseline to Week 16.
Part 2: Participants achieving a Psoriasis Area and Severity Index (PASI) 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Dimethyl fumarate (DMF) standard scheme (Drug)
Non-Germany: Dimethyl fumarate standard scheme
Part 1: Participants will receive Dimethyl fumarate (DMF) standard scheme from baseline to Week 16.
Part 2: Participants achieving a Psoriasis Area and Severity Index (PASI) 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Tildrakizumab (Drug)
Germany: Dimethyl fumarate standard scheme
Part 1: Participants will receive DMF standard scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Dimethyl fumarate (DMF) standard scheme (Drug)
Germany: Dimethyl fumarate standard scheme
Part 1: Participants will receive DMF standard scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Tildrakizumab (Drug)
Germany: Dimethyl fumarate simplified scheme
Part 1: Participants will receive DMF simplified scheme from Baseline to Week 16.
Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Dimethyl fumarate (DMF) simplified scheme (Drug)
Germany: Dimethyl fumarate simplified scheme
Part 1: Participants will receive DMF simplified scheme from Baseline to Week 16.
Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
干预措施: Tildrakizumab (Drug)
结局指标
主要结局
Part 2: Percentage of Participants Achieving a Psoriasis Area Severity Index 75 (PASI 75) after Tildrakizumab Treatment at Week 40
时间窗: Week 40
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). PASI 75 response, is defined as having an improvement (reduction) of greater than or equal to (\>=) 75% in PASI score compared to the baseline score.
次要结局
- Part 1 and Part 2: Percentage of Participants Achieving PASI 50, PASI 75, PASI 90 and PASI 100 (Only for Part 2) Responses(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Psoriasis Area Severity Index (PASI) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Body Surface Area (BSA) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Physician Global Assessment (PGA) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Percentage of Participants Achieving an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 5, 3 and 1(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Body Surface Area (BSA) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Percentage of Participants Achieving Scalp Physician Global Assessment (scPGA) Score of 0 or 1(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Percentage of Participants Achieving Palmoplantar Physician's Global Assessment (PPPGA) Score of 0 or 1(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Scalp Physician Global Assessment (scPGA) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Physician Global Assessment (PGA) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Dermatology Quality of Life Index (DLQI) Score(Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Skindex-16 Score(Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40)
- Part 1 and Part 2: Absolute Pruritus-Visual Analogue Scale (VAS) Score(Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, DMF: Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Absolute Medical Outcomes Study (MOS) Score(Part 1: Week 16; Part 2: Week 40)
- Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(From start of study drug administration up to Week 49)
- Percentage of Participants Withdrawing from Trial(From start of study drug administration up to Week 49)
- Part 1 and Part 2: Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 1 and Part 2: Percentage of Participants Achieving Dermatology Quality of Life Index (DLQI) Score of 0 or 1(Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score(Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40)
- Part 1 and Part 2: Absolute Skindex-16 Score(Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40)
- Part 1 and Part 2: Change from Baseline in Absolute Medical Outcomes Study (MOS) Score(Part 1: Baseline, Week 16; Part 2: Baseline, Week 40)
- Part 2: Percent Change from Baseline in Absolute Psoriasis Area Severity Index (PASI) Score(DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Physician Global Assessment (PGA) Score(DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score(DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score(DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score(Baseline, Weeks 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Skindex-16 Score(Baseline, Weeks 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score(DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40)
- Part 2: Percent Change from Baseline in Absolute Medical Outcomes Study (MOS) Score(Baseline, Week 40)
- Number of Participants with Treatment Compliance(From start of study drug administration up to Week 49)
- Percentage of Participants Using Topical Corticosteroids (TCS)(Part 1: Baseline up to Week 14; Part 2: Week 20 to Week 40)