PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 81
- 试验地点
- 20
- 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
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having chronic plaque psoriasis for at least 6 months
- •Able to withdraw all prior psoriasis treatments
- •Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study
排除标准
- •Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- •Pregnant or lactating women
- •Unwilling to use appropriate contraceptive methods
研究组 & 干预措施
2% CP-690,550 QD
干预措施: CP-690,550 (Drug)
0.2% CP-690,550 QD
干预措施: CP-690,550 (Drug)
0.02% CP-690,550 QD
干预措施: CP-690,550 (Drug)
2% CP-690,550 BID
干预措施: CP-690,550 (Drug)
0.2% CP-690,550 BID
干预措施: CP-690,550 (Drug)
0.02% CP-690,550 BID
干预措施: CP-690,550 (Drug)
Placebo Vehicle QD
干预措施: Placebo Vehicle (Drug)
Placebo Vehicle BID
干预措施: Placebo Vehicle (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
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
次要结局
- Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3(Baseline, Week 1, 2, 3)
- Number of Participants With Administration Site Adverse Events(Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days))
- Drug Plasma Concentrations of CP-690,555(0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28)
- Skin Biopsy Drug Concentrations(Day 28)
- Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions(Week 4)