JPRN-jRCT2011210069招募中2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus
Ranganathan Usha0 个研究点目标入组 20 人开始时间: 2022年2月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria >- 12 weeks before the screening visit
- •- Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid
- •(dsDNA) antibody, or anti-Smith antibody.
- •- Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score >- 6 points and clinical Hybrid SLEDAI score >- 4 points with joint involvement and/or rash
排除标准
- •- Active severe lupus nephritis (LN) as assessed by the investigator
- •- Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
- •- Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- •- Antiphospholipid Syndrome
研究者
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