NL-OMON54729招募中2 期
ong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis. - LTS16004
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi B.V.
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Participants must have completed treatment in the DRI15928 study
- •- Female participants must continue to use an acceptable effective
- •contraception method of birth control from inclusion and until the last study
- •dose, except if she has undergone sterilization at least 3 months earlier or is
- •postmenopausal.
排除标准
- •-The participant has a confirmed concomitant laboratory or ECG abnormality or
- •medical condition
- •deemed by the investigator incompatible with continuation of SAR442168
- •-The participant has received any live (attenuated) vaccine (including but not
- •limited to varicella
- •zoster, oral polio, and nasal influenza) between the last DRI15928 visit and
- •the first treatment visit
- •in the LTS16004 study.
- •-The participant has received a non-study MS disease modifying treatment
- •between the last IMP
- •treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement
- •Investigator may add unjustified risk to switching back and continuing
- •trreatment with SAR442168.
- •Washout periods after treatment with non-study DMTs should be respected except
- •for interferons or
- •glatiramer acetate treatment.
- •-The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8
- •hepatic enzymes.
- •Note: Such drugs need to be stopped at least 5 half-lives before study drug
- •administration.
- •The participant is receiving anticoagulant/antiplatelet therapies, including:
- •Acetylsalicylic acid (aspirin)
- •Antiplatelet drugs (eg, clopidogrel)
- •Warfarin (vitamin K antagonist)
- •Heparin, including low molecular weight heparin (antithrombin agents)
- •Dabigatran (direct thrombin inhibitor)
- •Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)
- •Note: All above drugs need to be stopped at least 5 half-lives before study
- •drug administration
- •except for aspirin, which needs to be stopped at least 8 days beforehand.
- •-Prior/concurrent clinical study experience
- •-The participant is taking part in another interventional clinical trial of
- •another drug substance.
- •-Uncooperative behavior or any condition that could make the participant
- •potentially non-adherent
- •with the study procedures
研究者
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