A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 854
- 试验地点
- 763
- 主要终点
- Percentage of Participants With Clinical Remission
研究概览
简要总结
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
- •Experience relapse or who complete the Maintenance Study
- •Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation
排除标准
- •Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
- •Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
- •Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of oral Ozanimod
干预措施: Ozanimod (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission
时间窗: At weeks 48, 96, 144, 192, 240
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)
A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. 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. Serious Adverse Events (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.
次要结局
- Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission(At weeks 48, 96, 144, 192, 240)
- Percentage of Participants With Clinical Response(At weeks 48, 96, 144, 192, 240)