A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 266
- 试验地点
- 24
- 主要终点
- Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
研究概览
简要总结
The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
- •Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
- •Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
排除标准
- •Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
- •Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
- •Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.
研究组 & 干预措施
Placebo BID
干预措施: placebo (Drug)
10mg BID CP-690,550
干预措施: CP-690,550 (Drug)
5mg BID CP-690,550
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
时间窗: Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16
时间窗: Week 16
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to Baseline.
次要结局
- Change From Baseline in DLQI Total Score at Week 4(Baseline to Week 4)
- Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline(Baseline to Week 16)
- Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16(Week 16 to Week 52)
- Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4(Week 4)
- Time to PASI50 Response up to Week 16(Baseline up to Week 16)
- Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16(Baseline to Week 16)
- Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16(Week 16)
- Change From Baseline in DLQI Total Score at Week 16(Baseline to Week 16)
- Percentage of Participants Achieving PASI75 Response at Week 4(Week 4)
- Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16(Week 16 to Week 52)
- Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16(Week 16 to Week 52)
- Percentage of Participants With PASI125 Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline(Baseline and Weeks 8, 16, 20, 32, 40, and 52)
- Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline(Baseline and weeks 8, 16, 20, 32, 40, and 52)
- Time to PGA Response up to Week 16(Baseline to Week 16)
- Time to PASI75 Response up to Week 16(Baseline up to Week 16)
- Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percentage of Participants in Each PGA Category Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percentage of Participants Achieving PASI75 Response Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Actual PASI Scores Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52)
- Change From Baseline in PASI Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- PASI Component Scores Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Change From Baseline in PASI Component Scores Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percent Change From Baseline in PASI Scores Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Actual BSA Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percent Change From Baseline in BSA Over Time Through Week 52(Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percentage of Participants With PASI50 Response Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percentage of Participants With PASI90 Response Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52(Baseline and Weeks 8, 16, 20, 32, 40, and 52)
- Percent Change From Baseline in NAPSI Over Time Through Week 52(Baseline and weeks 8, 16, 20, 32, 40, and 52)
- Percentage of Participants With NAPSI75 Response Over Time Through Week 52(Weeks 8, 16, 20, 32, 40, and 52)
- Percentage of Participants With NAPSI100 Response Over Time Through Week 52(Weeks 8, 16, 20, 32, 40, and 52)
- Actual Itch Severity Item (ISI) Score Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Change From Baseline in ISI Score Over Time Through Week 52(Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Change From Baseline in DLQI Score Over Time Through Week 52(Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52(Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52)
- Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52(Baseline, Weeks 16, 32, 40, 52)
- Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52(Baseline and weeks 16, 32, 40, and 52)
- Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52(Baseline and Weeks 16, 32, 40, and 52)
- Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52(Baseline and weeks 16, 32, 40, and 52)