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临床试验/2023-506477-35-00
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

Sun Pharmaceutical Industries Limited12 个研究点 分布在 2 个国家入组 63 人开始时间: 2024年2月2日最近更新:
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

申办方类型
Pharmaceutical company
责任方
主要研究者
主要研究者

Vasu Sadashivam

Scientific

Sun Pharmaceutical Industries Limited

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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