A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (IMPACT-PS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 33
- 主要终点
- Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)
研究概览
简要总结
Study to evaluate the efficacy and safety of JTE-451 administered for 16 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)
盲法说明
Double-blind
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
- •Have had a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1;
- •Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2
排除标准
- •History of discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator's judgment;
- •Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;
- •Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) at Visit 1;
- •History or presence of itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin within 12 months prior to Visit 1.
研究组 & 干预措施
JTE-451 Dose 1
JTE-451 Tablets Dose 1 daily for 16 weeks.
干预措施: JTE-451 Tablets (Drug)
JTE-451 Dose 2
JTE-451 Tablets Dose 2 daily for 16 weeks.
干预措施: JTE-451 Tablets (Drug)
Placebo
Placebo Tablets daily for 16 weeks.
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)
时间窗: End of Treatment (Up to 16 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 at EOT (up to 16 weeks) relative to Baseline.
次要结局
- Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT(End of Treatment (Up to 16 Weeks))
- Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT(End of Treatment (Up to 16 Weeks))
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT(End of Treatment (Up to 16 Weeks))
- Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT(End of Treatment (Up to 16 Weeks))
- Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in the Skindex-16 Overall Score at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT(End of Treatment (Up to 16 Weeks))
- Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT(End of Treatment (Up to 16 Weeks))
- Number of Subjects With Treatment-emergent Adverse Events(Follow-up (Up to 20 Weeks))
- JTE-451 Trough Plasma Concentrations at Week 16(Week 16)