EUCTR2016-003292-22-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Fulfilled revised American European US Consensus Group
- •criteria for pSS
- •- Seropositive at screening for anti-Ro/SSA antibodies
- •diagnosis prior to the baseline visit
- •- Other protocol-defined inclusion/exclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •- Secondary Sjogren’s syndrome
- •- Use of other investigational drugs
- •- Active viral, bacterial or other infections
- •- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at
- •- Other protocol-defined inclusion/exclusion criteria may apply
研究者
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