An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 41
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
排除标准
- •Women who are pregnant or breastfeeding
- •Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Long-Term Extension Rollover Study: Deucravacitinib
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
时间窗: From first dose to 30 days post last dose (Up to 110 weeks)
Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment
Number of Participants With Laboratory Abnormalities
时间窗: From first dose to 30 days post last dose (Up to 110 weeks)
Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
Number of Participants With Electrocardiogram (ECG) Abnormalities
时间窗: From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities
时间窗: From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters
时间窗: Baseline, Week 12, Week 108
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
时间窗: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Change From Baseline in Electrocardiogram (ECG) Parameters
时间窗: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Change From Baseline in Vital Signs Parameters - Heart Rate
时间窗: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters - heart rate
Change From Baseline in Vital Signs Parameters
时间窗: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters
次要结局
未报告次要终点