Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 125
- 试验地点
- 37
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
Primary Objective:
To determine the long-term safety and tolerability of SAR442168 in RMS participants
Secondary Objective:
To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods
详细描述
Approximately 62 months including the 8 weeks post-treatment visit
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR442168
SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose was administered in the DRI15928 study until selection of Phase 3 dose.
Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants were switched to this 60 mg dose.
干预措施: Tolebrutinib (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the respective on-treatment periods.
次要结局
- Mean Number of New Gadolinium (Gd)-Enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192(Weeks 192 and 240)
- Mean Number of New or Enlarging T2 Lesions at Week 240 Relative to Week 192(Weeks 192 and 240)
- Total Mean Number of Gd-enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192(Weeks 192 and 240)
- Annualized Relapse Rate (ARR)(From Baseline (enrollment in LTS16004, Day 1) to Week 240)
- Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 240(Baseline (Day 1 of DRI15928) and Week 240)