An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 8
- 主要终点
- To determine the long-term safety and tolerability of tolebrutinib in participants with RMS and PMS
研究概览
简要总结
The goal of this Phase 3 extension study is to demonstrate long-term safety and tolerability of tolebrutinib in participants with different forms of MS who participated in the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal tolebrutinib studies. Long-term efficacy will also be assessed by key secondary endpoints evaluating disability progression, relapse rate (only in participants with RMS), number of new or enlarging T2-hyperintense lesions, and T2 lesion volume. Together with evaluation of other secondary and tertiary endpoints, this study will provide a comprehensive evaluation of the long-term safety, tolerability, and efficacy of tolebrutinib in the MS population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal tolebrutinib studies (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
- •I02: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •The participant is capable of giving signed informed consent.
排除标准
- •The participant is at risk for or has a persistent chronic, active (including fever ≥38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator.
- •For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection.
- •See the Study Manual for further details.
- •Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit.
结局指标
主要结局
To determine the long-term safety and tolerability of tolebrutinib in participants with RMS and PMS
时间窗: 60 months
次要结局
- To assess long-term efficacy of OL tolebrutinib on disability progression, relapse rate (only in participants with RMS), and MRI parameters in participants with RMS and PMS(60 months)