NCT03440372终止3 期
Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 625
- 试验地点
- 408
- 主要终点
- Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
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 therapies
- •Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- •An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- •Has 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
- •Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- •Has 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
Experimental
干预措施: Ozanimod (Drug)
Administration of Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
时间窗: At Week 12
Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI uses 8 variables: number of soft/liquid stools, severity of abdominal pain (0=none to 3=severe), general well-being (0=well to 4=terrible), presence of complications, need for antidiarrheal drugs, presence of abdominal mass, hematocrit, and change in body weight. Scores for stool number, abdominal pain, and well-being are summed over the 7 days before each visit. The other factors are also recorded and weighted to create a total CDAI score, which ranges from 0-600, with higher scores indicating worse disease (score 150-219 = mild, 220-450 = moderate, \>450 = severe). This measure reports the percentage of participants whose CDAI score was below 150 at 12 weeks.
次要结局
- Percent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12(At Week 12)
- Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12(At Week 12)
- Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12(At Week 12)
- Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12(At Week 12)
- Percent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12(At Week 12)
- Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12(At Week 12)
- Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12(At Week 12)
- Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12(At Week 12)
- Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12(At Week 12)
- Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12(At Week 12)
- Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12(At Week 12)
研究者
研究点 (408)
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