A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy 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
- 550
- 试验地点
- 762
- 主要终点
- Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed
研究概览
简要总结
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in 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
- •Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- •In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study
排除标准
- •Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- •Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Ozanimod
干预措施: Ozanimod (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed
时间窗: Week 52
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.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores
时间窗: Week 52
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
次要结局
- Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed(Week 52)
- Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52(Week 52)
- Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1(Week 52)
- Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1(Week 52)
- Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases(Week 52)
- Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores(Week 52)
- Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52(Week 52)
- Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52(Week 52)
- Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases(Week 52)
- Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1(Week 52)
- Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52(Week 52)
- Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD(Week 52)
- Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52(Week 52)
- Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1(Week 52)
- Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52(Week 52)