A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 258
- 试验地点
- 58
- 主要终点
- Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24
研究概览
简要总结
This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).
The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- •Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline
排除标准
- •Secondary or primary progressive multiple sclerosis
研究组 & 干预措施
Ozanimod 0.5 mg
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.
干预措施: Ozanimod (Drug)
Ozanimod 1 mg
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.
干预措施: Ozanimod (Drug)
Placebo
Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
干预措施: Ozanimod (Drug)
Placebo
Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24
时间窗: From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
次要结局
- The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24(Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure(From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively.)
- The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24(Week 24)
- Adjusted Annualized Relapse Rate (ARR) at Week 24(Week 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period(From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.)