A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 212
- 试验地点
- 44
- 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
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of 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
- 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
- •Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
- •Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
- •Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
- •Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)
排除标准
- •Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
- •Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
- •Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
- •Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
- •Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
- •Have undergone treatment with tofacitinib within 3 months of first dose.
研究组 & 干预措施
PF-06700841 30mg once daily followed by 100mg once weekly
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
干预措施: PF-06700841 (Drug)
PF-06700841 60 mg followed by 30 mg once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
干预措施: PF-06700841 (Drug)
PF-06700841 60 mg followed by 10 mg once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
干预措施: PF-06700841 (Drug)
PF-06700841 60mg once daily followed by 100mg once weekly
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
干预措施: PF-06700841 (Drug)
PF-06700841 60mg once daily followed by placebo once daily
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
干预措施: PF-06700841 (Drug)
PF-06700841 30mg once daily
4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
干预措施: PF-06700841 (Drug)
PF-06700841 30mg once daily followed by 10mg once daily
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
干预措施: PF-06700841 (Drug)
Placebo
12 weeks once daily placebo
干预措施: Placebo (Other)
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 (Day 1 pre-dose), Week 12
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose of study treatment (Day 1) up to Week 20)
- Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs(From first dose of study treatment (Day 1) up to Week 20)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16(Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16)
- Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16(Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16)
- Number of Participants With Any Post-Baseline Laboratory Test Abnormalities(From first dose of study treatment (Day 1) up to Week 16)
- Change From Baseline in Blood Lipid Level at Weeks 4 and 12(Baseline (Day 1 pre-dose), Weeks 4 and 12)
- Number of Participants With Post-Baseline Vital Sign Abnormalities(From first dose of study treatment (Day 1) up to Week 16)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12(Week 12)
- Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16(Weeks 1, 2, 4, 6, 8, 10, 14, 16)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16(Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16)
- Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16(Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16)
- Change From Baseline in PASI Scores at Week 4 by Induction Dose(Baseline (Day 1 pre-dose), Week 4)
- Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities(From first dose of study treatment (Day 1) up to Week 16)