A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 344
- 试验地点
- 77
- 主要终点
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
研究概览
简要总结
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •plaque psoriasis for 6 months
- •PGA score mild or moderate
- •body surface area (BSA) 2-15%
排除标准
- •other skin conditions that would interfere with the evaluation of psoriasis
- •history of herpes zoster or simplex
- •Infected with Mycobacterium tuberculosis
研究组 & 干预措施
Vehicle cream QD
Vehicle cream applied once daily (QD)
干预措施: Vehicle (Placebo) (Drug)
PF-06700841 0.1% cream QD
PF-06700841 0.1% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 0.3% cream QD
PF-06700841 0.3% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 1% cream QD
PF-06700841 1% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 3% cream QD
PF-06700841 3% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 0.3% cream BID
PF-06700841 0.3% cream applied twice daily (BID)
干预措施: PF-06700841 (Drug)
PF-06700841 1% cream BID
PF-06700841 1% cream applied twice daily (BID)
干预措施: PF-06700841 (Drug)
Vehicle cream BID
Vehicle cream applied twice daily (BID)
干预措施: Vehicle (Placebo) (Drug)
PF-06700841 3% cream BID
PF-06700841 3% cream applied twice daily (BID)
干预措施: PF-06700841 (Drug)
结局指标
主要结局
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
时间窗: Baseline, Week 12
The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
次要结局
- Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2(Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET))
- Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2(Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET))
- Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16(Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16)
- Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16(Week 1, 2, 4, 6, 8, 10, 12, 14, and 16)
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs(Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With TEAEs by Severity(Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants Who Discontinued From Study Due to Adverse Events(Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Laboratory Abnormalities Meeting Specified Criteria(Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks))
- Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Absolute PP-NRS Score at Week 14 and 16(Week 14 and 16)
- Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Change From Baseline in PP-NRS Score at Week 14 and 16(Baseline, Week 14 and 16)
- Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12(Baseline, Week 12)
- Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16(Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16)
- Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Change From Baseline in PASI Scores at Week 14 and 16(Baseline, Week 14 and 16)
- Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Percent Change From Baseline in PASI Scores at Week 14 and 16(Baseline, Week 14 and 16)
- Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data(Post-baseline to Week 6, Post-baseline to Week 12)
- Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data(Post-baseline to Week 12)
- Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16(Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16)