Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
研究概览
简要总结
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
详细描述
This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Male or female aged 18 to 65 years (inclusive).
- •Patients with advancing RMS as defined by the principal investigator.
- •Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
- •EDSS score of >/= 2.0 to 6.5 (inclusive).
- •Having been continuously treated with RMS Disease Modifying Therapies.
- •Key Exclusion criteria:
- •Pregnant or nursing (lactating) women.
- •Patients with any medically unstable condition as determined by the investigator.
- •Certain cardiac risk factors defined in the protocol
- •History of hypersensitivity to the study drug or to drugs of similar chemical classes.
- •Other protocol-defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Siponimod
Participants will receive titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months.
As of protocol amendment 3, participants entering the trial converting from fingolimod will start directly with 2 mg dose of siponimod.
干预措施: Siponimod (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
时间窗: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date of the last actual administration, or events present prior to start of treatment but which increased in severity. TEAEs suspected to be related to study drug are reported.
次要结局
- Number of Participants With at Least One Adverse Event (AE)(From first dose of study drug up to 30 days after last dose of study drug (up to 7 months))
- Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline up to Day 168)
- Change in Heart Rate From Baseline to 6 Hours After First Treatment(From the first dose up to 6 hours)
- Number of Participants With at Least One Hospitalization During the Treatment(From first dose of study drug up to last dose of study drug (up to 6 months))
- Patient Retention Reported as Number of Participants Who Completed the Study(From first dose of study drug up to 30 days after last dose of study drug (up to 7 months))