A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 50
- 主要终点
- Proportion of subjects with at least 75% improvement in PASI (PASI 75)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 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
- Double (Participant, Investigator)
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
- •Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.
- •Aged at least 18 years.
- •Subjects with no history of active TB or symptoms of TB
排除标准
- •Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
- •Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
- •Subjects with history or presence of uveitis
研究组 & 干预措施
Placebo of SCD-044 product
Placebo of SCD-044 study drug
干预措施: Placebo (Drug)
SCD-044 Tablets_Dose 1
SCD-044 tablets at Dose 1
干预措施: SCD-044_Dose 1 (Drug)
SCD-044 Tablets_Dose 2
SCD-044 tablets at Dose 2
干预措施: SCD-044_Dose 2 (Drug)
SCD-044 Tablets_Dose 3
SCD-044 tablets at Dose 3
干预措施: SCD-044_Dose 3 (Drug)
结局指标
主要结局
Proportion of subjects with at least 75% improvement in PASI (PASI 75)
时间窗: Week16
The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity.
次要结局
- Psoriasis Area and Severity Index (PASI) response rate(Week 52)
- Change in Psoriasis symptoms and signs diary (PSSD)(Week 52)
- Evaluate pharmacokinetic parameter(Week 52)
- Subjects with adverse events(Week 56)
- Change in Psoriasis Area and Severity Index (PASI) scores(Week 52)
- Change in body surface area (BSA)(Week 52)
- Patient Global Impression of Severity (PGIS)(Week 52)
- Patient Global Impression of Change (PGIC)(Week 52)
- Investigator's Global Assessment (IGA) score(Week 52)
- Change in Dermatology Life Quality Index (DLQI)(Week 52)