A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as 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
- 877
- 试验地点
- 41
- 主要终点
- Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
详细描述
This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.
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
- •Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
排除标准
- •Receiving treatment with breast cancer resistance protein inhibitors
- •Clinically relevant cardiovascular conditions
- •Liver function impairment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
RPC0163 (Ozanimod)
干预措施: RPC1063 (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
时间窗: From first dose to 90 days post last dose (Up to approximately 92 months)
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
次要结局
- Percentage of Participants With Clinical Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Clinical Response(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Endoscopic Improvement(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Corticosteroid-free Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants With Histologic Remission(Week 46, 94, 142, 190, 238)
- Change From Baseline in Partial Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Percentage of Participants With Mucosal Healing(Week 46, 94, 142, 190, 238)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response(Week 46, 94, 142, 190, 238)
- Change From Baseline in Complete Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Change From Baseline in 9-Point Mayo Score(Baseline, week 46, 94, 142, 190, 238, 286, 334, 382)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission(Week 46, 94, 142, 190, 238)
- Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement(Week 46, 94, 142, 190, 238)