Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 606
- 试验地点
- 368
- 主要终点
- Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
研究概览
简要总结
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Crohn's disease for ≥ 3 months on endoscopy and on histological exam
- •Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
- •Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- •Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- •Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
排除标准
- •Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- •Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
- •Current stoma, ileal-anal pouch anastomosis, or fistula
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of oral Ozanimod
干预措施: Ozanimod (Drug)
Administration of Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
时间窗: Week 12
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.
次要结局
- Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission(Week 12)
- Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%(Week 12)
- Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150(Week 12)
- Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%(Week 12)
- Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response(Week 12)
- Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12(Week 12)
- Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%(Week 12)
- Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%(Week 12)
- Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points(Week 12)
- Percentage of Participants With Global Histologic Activity Score (GHAS) Remission(Week 12)
- Percentage of Participants With CDAI Reduction From Baseline of >=70 Points(Week 12)
- Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%(Week 12)