A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 24-Week Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) Extended Release Tablets in Subjects With Moderate-to-Severe Plaque Psoriasis (AFFIRM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 74
- 主要终点
- Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US).
Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms:
- PPC-06 400 mg once daily (QD)
- PPC-06 400 mg BID
- PPC-06 600 mg BID
- Placebo BID The maximum study duration for each subject will be approximately 29 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
- •Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent).
- •Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject).
- •Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline [Day 0] visit):
- •PASI score of ≥12
- •Total body surface area (BSA) affected by plaque psoriasis of ≥10%
- •IGA score of >3
- •Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
排除标准
- •Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis).
- •Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening.
- •Subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the Baseline Visit.
- •Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the Baseline Visit.
- •Subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit:
- •Etanercept - 35 days
- •Infliximab, adalimumab - 12 weeks
- •Ustekinumab - 24 weeks
- •Any other biologic agent <5 half-lives prior to the Baseline Visit
- •Subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).
研究组 & 干预措施
Placebo BID
White placebo tablet to mimic Tepilamide Fumarate
干预措施: Placebo (Drug)
PPC-06 400 mg BID
Tepilamide Fumarate 400 mg twice per day
干预措施: PPC-06 400 mg BID (Drug)
PPC-06 600 mg BID
Tepilamide Fumarate 600 mg twice per day
干预措施: PPC-06 600 mg (Drug)
PPC-06 400 mg QD
Tepilamide Fumarate 400 mg once per day
干预措施: PPC-06 400 mg QD (Drug)
结局指标
主要结局
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24
时间窗: End of Week 24
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1
时间窗: End of Week 24
The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1) Score Grade Definition 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.
次要结局
未报告次要终点