A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 22
- 主要终点
- Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
研究概览
简要总结
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
详细描述
The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.
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
- •Clinical diagnosis of psoriasis for at least 6 months.
- •Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
- •Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
- •Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
- •Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
排除标准
- •Diagnosis of other active skin diseases or skin infections.
- •Participant has known hypersensitivity to adalimumab or it excipients.
- •Participant has chronic recurring infections or active tuberculosis.
- •Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- •Participant is known to have immune deficiency or is immunocompromised.
结局指标
主要结局
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
时间窗: Week 12
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
次要结局
- Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A](Weeks 3 and 7)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B](Weeks 16, 19, and 24)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A](Baseline to Week 12)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B](Baseline to Week 24)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A](Weeks 3, 7, and 12)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B](Weeks 16, 19, and 24)
- Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A](Baseline and Weeks 3, 7, and 12)
- Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B](Weeks 16, 19, and 24)
- Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A](Baseline and Weeks 3, 7, and 12)
- Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B](Weeks 16, 19, and 24)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A](Baseline, Week 3, and Week 12)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B](Week 16 and Week 24)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A](Baseline, Week 3, and Week 12)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B](Week 16 and Week 24)
- Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A](Baseline to Week 12)
- Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B](Baseline to Week 24)