A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 1,012
- 试验地点
- 371
- 主要终点
- Percentage of Participants in Clinical Remission at 10 Weeks
研究概览
简要总结
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
详细描述
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
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
- •Aged 18 to 75 years (at screening for Cohort 1 and 2)
- •UC confirmed on endoscopy
- •Moderately to severely active UC (May score 6-12)
- •Currently receiving treatment with aminosalisylate, prednisone, or budesonide
- •Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
排除标准
- •Have severe extensive colitis as evidence by:
- •Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
- •Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
- •Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
- •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 unknown macular edema
- •Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
研究组 & 干预措施
RPC1063 (Ozanimod)
1mg, daily oral administration during Induction and Maintenance periods.
干预措施: RPC1063 (Drug)
Placebo
Daily oral administration during Induction and Maintenance periods.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission at 10 Weeks
时间窗: At 10 Weeks
Percentage of participants that are in Clinical remission at 10 weeks
Percentage of Participants in Clinical Remission at 52 Weeks
时间窗: At 52 Weeks
Percentage of participants that are in Clinical remission at 52 weeks
次要结局
- Percentage of Participants With Endoscopic Improvement at 10 Weeks(At 10 Weeks)
- Percentage of Participants With Endoscopic Improvement at 52 Weeks(At 52 Weeks)
- Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10(At 52 Weeks)
- Percentage of Participants With Clinical Response at 10 Weeks(At 10 Weeks)
- Percentage of Participants With Mucosal Healing at 10 Weeks(At 10 Weeks)
- Percentage of Participants in Clinical Response at 52 Weeks(At 52 Weeks)
- Percentage of Participants With Corticosteroid Free Remission at 52 Weeks(At 52 Weeks)
- Percentage of Participants With Mucosal Healing at 52 Weeks(At 52 Weeks)
- Percentage of Participants With Durable Clinical Remission at 52 Weeks(At 52 Weeks)