EUCTR2019-001673-93-DK进行中（未招募）1 期
An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials
Boehringer Ingelheim BV0 个研究点目标入组 20 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
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 in accordance with GCP and local legislation prior to admission into the trial.
- •- Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
相似试验
进行中（未招募）
1 期
A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.Crohns diseaseMedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856EUCTR2019-001673-93-HUBoehringer Ingelheim RCV GmbH & Co KG20
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.chronic inflammation of digestive tractCrohn disease10017969NL-OMON52849Boehringer Ingelheim1
进行中（未招募）
1 期
A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.MedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856Crohn's diseaseEUCTR2019-001673-93-DEBoehringer Ingelheim Pharma GmbH & Co. KG20
进行中（未招募）
1 期
A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.Crohns diseaseMedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856EUCTR2019-001673-93-BEBoehringer Ingelheim20
进行中（未招募）
1 期
A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.Crohns diseaseMedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856EUCTR2019-001673-93-ATBoehringer Ingelheim20