A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.
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
- •Have been diagnosed with plaque psoriasis for at least 6 months.
- •Have plaque psoriasis covering at least 15% of their total body.
- •Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
- •Be willing and able to comply with scheduled visits, treatment plan and other study procedures.
排除标准
- •Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
- •Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
- •Subject is participating in another trial using an investigational agent or procedure.
- •Women who are pregnant or breast-feeding or considering becoming pregnant.
研究组 & 干预措施
4
干预措施: Placebo (Drug)
1
干预措施: CP-690,550 (Drug)
2
干预措施: CP-690,550 (Drug)
3
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12
时间窗: Week 12
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
次要结局
- Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"(Week 2, 4, 8, 12, 14, 16)
- Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score(Week 2, 4, 8, 14, 16)
- Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score(Week 2, 4, 8, 12, 14, 16)
- Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score(Week 12)
- Psoriasis Area and Severity Index (PASI) Component Scores and Total Score(Baseline, Week 2, 4, 8, 12, 14, 16)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16(Baseline, Week 2, 4, 8, 12, 14, 16)