A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 76
- 主要终点
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.
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
- Double (Participant, Investigator)
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
- •Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
- •Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
- •≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
- •Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
- •Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1
排除标准
- •Target Disease Exceptions:
- •Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Deucravacitinib
干预措施: Deucravacitinib (Drug)
Placebo then Deucravacitinib
干预措施: Placebo (Other)
Placebo then Deucravacitinib
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
时间窗: At Week 16
Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
时间窗: At Week 16
Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.
次要结局
- Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(At Week 16)
- Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16(Baseline and at Week 16)
- Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16(At Week 16)
- Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16(From Week 0 through Week 16)
- Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16(Baseline and at Week 16)
- Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16(At Week 16)
- Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16(From Week 0 through Week 16)
- Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16(From Week 0 through Week 16)
- Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(At Week 16)