A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 16
- 主要终点
- Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
研究概览
简要总结
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
- •Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
- •Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
- •Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
- •Body Mass Index (BMI) ≤40 at Visit 1.
排除标准
- •Medical history of treatment failure to any systemic agents for plaque psoriasis;
- •Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
- •Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
- •History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
- •History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);
研究组 & 干预措施
JTE-051 Dose 3
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
JTE-051 Dose 4
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
Placebo
One dose of study drug by mouth daily for 12 weeks
干预措施: Placebo (Drug)
JTE-051 Dose 1
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
JTE-051 Dose 2
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
结局指标
主要结局
Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
时间窗: Up to 12 Weeks
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score relative to Baseline.
次要结局
- Percent Change From Baseline in PASI Score(Week 12)
- Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)(Week 12)
- Change From Baseline in Static Physician's Global Assessment (sPGA) Score(Week 12)
- Change From Baseline in the Skindex-16 Emotions Scale Score(Week 12)
- Number of Subjects With Treatment-emergent Adverse Events(Up to 16 Weeks)
- Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)(Week 12)
- Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)(Week 12)
- Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1(Week 12)
- Percent Change From Baseline in Psoriasis Body Surface Area (BSA)(Week 12)
- Change From Baseline in the Skindex-16 Overall Score(Week 12)
- Change From Baseline in the Skindex-16 Symptoms Scale Score(Week 12)
- Change From Baseline in the Skindex-16 Functioning Scale Score(Week 12)
- JTE-051 Trough Plasma Concentrations(Week 12)