NCT01246583已完成2 期
A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 71
- 试验地点
- 12
- 主要终点
- Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
研究概览
简要总结
The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
- •A target plaque of at least 9 sq. cm.
排除标准
- •Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
- •Non plaque form of psoriasis;
- •Currently have or history of psoriatic arthritis;
- •Current drug induced psoriasis;
- •Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
- •Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
研究组 & 干预措施
Treatment Group A
Experimental
干预措施: CP-690,550 Ointment 1 (Drug)
Treatment Group B
Placebo Comparator
干预措施: Vehicle 1 (Drug)
Treatment Group C
Experimental
干预措施: CP-690,550 Ointment 2 (Drug)
Treatment Group D
Placebo Comparator
干预措施: Vehicle 2 (Drug)
结局指标
主要结局
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
时间窗: Baseline, Week 4
Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.
次要结局
- Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score(Week 1, 2, 3, 4)
- Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4(Baseline, Week 1, 2, 3, 4)
- Itch Severity Item (ISI)(Baseline, Week 1, 2, 3, 4)
- Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4(Baseline, Week 1, 2, 3, 4)
- Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category(Week 4)
- Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area(Baseline, Week 1, 2, 3, 4)
- Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3(Baseline, Weeks 1, 2, 3)
- Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4(Baseline, Weeks 1, 2, 3, 4)
- Number of Participants With Administration Site Adverse Events(Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks))
- Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1)(Week 1, 2, 3, 4)
- Number of Participants With Draize Score of Perilesional Skin in The Treatment Area(Baseline, Week 1, 2, 3, 4)
- Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4(Baseline, Week 1, 2, 3, 4)
- Change From Baseline in Heart Rate at Week 1, 2, 3, 4(Baseline, Week 1, 2, 3, 4)
- Change From Baseline in Electrocardiogram (ECG) Findings at Week 4(Baseline, Week 4)
- Change From Baseline in Hemoglobin Level at Week 2, 4(Baseline, Week 2, 4)
- Change From Baseline in Creatinine Level at Week 2, 4(Baseline, Week 2, 4)
- Change From Baseline in Platelet and Neutrophil Count at Week 2, 4(Baseline, Week 2, 4)
- Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4(Baseline, Week 2, 4)
- Plasma Concentration of CP-690,550(0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination)
研究者
研究点 (12)
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