临床试验/NCT02307643

NCT02307643已完成1 期

An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)

Mitsubishi Tanabe Pharma Corporation2 个研究点分布在 1 个国家目标入组 17 人开始时间: 2015年2月最近更新: 2017年6月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Mitsubishi Tanabe Pharma Corporation
入组人数: 17
试验地点: 2
主要终点: Number of Subjects with Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
•Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
•Stable doses of corticosteroids

排除标准

•Severe active lupus nephritis, neuropsychiatric SLE

研究组 & 干预措施

Part 2-A

Experimental

MT-1303 High dose+Corticosteroid

干预措施: MT-1303 High dose (Drug)

Part 1

Experimental

MT-1303 Low dose+Corticosteroid

干预措施: MT-1303 Low dose (Drug)

Part 2-B

Experimental

MT-1303 Low dose+Corticosteroid+Immunosuppressant

干预措施: MT-1303 Low dose (Drug)

结局指标

主要结局

Number of Subjects with Adverse Events

时间窗: up to 36 weeks

次要结局

Change from Baseline in anti-dsDNA and complement(baseline and 24 weeks)
Change from Baseline in Lymphocyte counts(baseline and 24 weeks)

研究者

发起方

Mitsubishi Tanabe Pharma Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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