A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 69
- 试验地点
- 28
- 主要终点
- Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.
研究概览
简要总结
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
详细描述
This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.
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
- •Crohn's disease (CD) confirmed by endoscopy and histology
- •Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
- •Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy
排除标准
- •Diagnosis of ulcerative colitis or indeterminate colitis
- •Known strictures/stenosis leading to symptoms of obstruction
- •Current stoma or need for ileostomy or colostomy
- •Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
- •History of uveitis or known macular edema
- •History of colonic dysplasia
研究组 & 干预措施
RPC1063 (Ozanimod)
干预措施: RPC1063 (Drug)
结局指标
主要结局
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.
时间窗: Baseline to Week 12
The simple endoscopy score (SES-CD) assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.
次要结局
- The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period(From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years)