An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 38
- 主要终点
- Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged ≥18 years
- •Signed and dated written informed consent for 1368.17, 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. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
排除标准
- •Have experienced study treatment-limiting adverse events during induction treatment with study drug
- •Have developed any of the exclusion criteria from the original induction study with the following exceptions:
- •Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17
- •Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines
研究组 & 干预措施
Spesolimab IV infusion
Spesolimab IV infusion
干预措施: Spesolimab (Drug)
Spesolimab SC solution for injection
Spesolimab SC solution for injection
干预措施: Spesolimab (Drug)
结局指标
主要结局
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)
时间窗: From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.
Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE). The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years). Only participants receiving maintenance treatment were analysed for this endpoint.
次要结局
- Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment(Up to 336 weeks)