2023-506477-35-00招募中2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 16
研究概览
简要总结
To determine the effect of SCD-044 treatment on moderate to severe plaque psoriasis, as measured by proportion of subjects showing at least 75% improvement in Psoriasis Area and Severity Index (PASI) at Week 16.
入排标准
- 年龄范围
- 18 years 至 65+ years(65+ Years, 18-64 Years)
- 接受健康志愿者
- 是
入选标准
- Males and non-pregnant non-lactating females ≥ 18 years of age providing written informed consent prior to any study-related procedures
- Diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator
- Subject is a candidate for phototherapy or systemic therapy for plaque psoriasis.* *Note: Subjects are required to be candidates for systemic/phototherapy, however no such therapy will be allowed during the study. Please refer to exclusion criteria 3
- Moderate to severe plaque psoriasis at Screening and Baseline defined as: • BSA involvement of ≥ 10% • PASI score of ≥ 12 • IGA of at least moderate disease (≥ 3)
排除标准
- Predominantly non-plaque forms of psoriasis like erythrodermic psoriasis, pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new-onset guttate psoriasis
- History or presence of uveitis
结局指标
主要结局
Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 16
Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 16
次要结局
未报告次要终点
研究者
研究点 (12)
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标识符
- 欧盟试验编号
- 2023-506477-35-00
- 其他研究编号
- SCD-044-19-14, NCT04566666
日期
- 首次发布
- (2年前)
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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