NL-OMON52849已完成2 期
An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn*s disease who have completed previous spesolimab trials. - 1368-0007: Long-term spesolimab in patients with fistulising CD.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
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
- 18 至 99（—）
入选标准
- •- Patient older than 18 years
- •- Has completed all treatments (placebo or active treatment) and the EOT visit
- •in the parent induction trial in fistulising CD and is willing and able to
- •continue treatment in 1368-0007
- •- Has obtained an individual health benefit, per investigator judgement (such
- •as fistula response or remission or other clinical improvement), from treatment
- •in the parent trial
- •- Signed and dated written informed consent for 1368-0007
- •- Women of childbearing potential (WOCBP) must be ready to use highly effective
- •methods of birth control
排除标准
- •- Have experienced treatment-limiting adverse events during induction treatment
- •with study drug
- •- Have developed any condition which meets the exclusion criteria from the
- •original induction study
- •- Any condition which in the opinion of the investigator affects the safety or
- •ability to participate in this trial
研究者
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