An Exploratory Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess Mechanism Of Action (Moa) Of Cp-690,550 In The Skin When Administered Orally At 10 Mg Twice Daily (Bid) For 12 Weeks In 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
- 12
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
研究概览
简要总结
There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.
详细描述
The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.
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
- Triple (Participant, 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
- •Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.
排除标准
- •Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
- •Use of oral or injected corticosteroids (steroids).
研究组 & 干预措施
Cohort 1
干预措施: (CP-6890,550) Tofacitinib (Drug)
Cohort 1
干预措施: Placebo (Drug)
Cohort 2
干预措施: Placebo (Drug)
Cohort 2
干预措施: (CP-690,550) Tofacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
时间窗: Week 12
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.
Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12
时间窗: Week 12
Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 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%) to 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) summed over all sections.
次要结局
- Percent Change From Baseline in PASI by Visit(Weeks 1, 2, 4, and 12)
- Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category(Baseline and Weeks 1, 2, 4, and 12)
- Percentage of Participants by PGA Response Category and Timepoint(Baseline and Weeks 1, 2, 4, and 12)
- Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4(Weeks 1, 2, and 4)
- Change From Baseline in BSA(Weeks 1, 2, 4, and 12)
- Percent Change From Baseline in BSA(Weeks 1, 2, 4, and 12)
- Change From Baseline in ISI by Visit(Weeks 1, 2, 4 and 12)
- Percent Change From Baseline in TPSS by Visit(Weeks 1, 2, 4, and 12)
- Body Surface Area (BSA)(Baseline and Weeks 1, 2, 4, and 12)
- Psoriasis Area and Severity Index (PASI) Score by Visit(Baseline and Weeks 1, 2, 4, and 12)
- Itch Severity Item (ISI) Score by Visit(Baseline and Weeks 1, 2, 4, and 12)
- Target Plaque Severity Score (TPSS) by Visit(Baseline and Weeks 1, 2, 4, and 12)
- Change From Baseline in PASI by Visit(Weeks 1, 2, 4 and 12)
- Change From Baseline in PGA Score by Visit(Weeks 1, 2, 4, and 12)