A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 476
- 试验地点
- 52
- 主要终点
- Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12
研究概览
简要总结
The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 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
- 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 mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
- •At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
- •If received certain treatments, should be off treatment for a minimum period of time (washout)
排除标准
- •Currently have non-plaque forms of psoriasis or drug-induced psoriasis
- •Require treatment with or cannot stop medication(s) prohibited during the study
- •Have certain laboratory abnormalities at Baseline
- •Current or history of certain infections
- •Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
研究组 & 干预措施
Treatment Group A
干预措施: tofacitinib ointment 20 mg/g (Drug)
Treatment Group B
干预措施: tofacitinib ointment 10 mg/g (Drug)
Treatment Group C
干预措施: placebo ointment (vehicle) (Drug)
Treatment Group D
干预措施: tofacitinib ointment 20 mg/g (Drug)
Treatment Group E
干预措施: tofacitinib ointment 10 mg/g (Drug)
Treatment Group F
干预措施: placebo ointment (vehicle) (Drug)
结局指标
主要结局
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12
时间窗: Baseline, Week 12
Clinical signs of plaque psoriasis (erythema \[E\], induration \[I\], and scaling \[S\]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8
时间窗: Baseline, Week 8
Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
次要结局
- Percent Change From Baseline to Week 8 in PASI(Baseline, Week 8)
- Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12(Week 12)
- Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8(Week 8)
- Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis(Baseline, Week 12)
- Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis(Baseline, Week 8)
- Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores(Baseline, Week 12)
- Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8(Baseline, Week 8)
- Change From Baseline to Week 8 in Clinic-Based ISI Scores(Baseline, Week 8)
- Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score(Baseline, Week 12)
- Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline(Baseline, Week 12)
- Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline(Baseline, Week 8)
- Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8(Baseline, Week 8)
- Change From Baseline to Week 8 in the DLQI Total Score(Baseline, Week 8)