CTIS2023-509345-12-00招募中1 期
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - CLOU064C12301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 800
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（—）
- 性别
- All
入选标准
- •Signed informed consent obtained prior to any assessment performed (confirm at screening visit), Male or female participants 18 to 55 years of age (inclusive) at screening, Diagnosis of RMS according to the 2017 McDonald diagnostic criteria (this would include RRMS or active SPMS) as confirmed at screening visit, At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening, EDSS score of 0 to 5.5 (inclusive) at screening and randomization, Neurologically stable within 1 month prior to screening and randomization (including no Multiple Sclerosis (MS) relapse in this period)
排除标准
- •Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening, Use of exclusionary medication prior to screening/randomization, Requirement for anticoagulant medication (e.g. warfarin or Novel Anti-Coagulants (NOAC)) or use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel). The use of acetylsalicylic acid up to 100 mg/day or clopidogrel up to 75 mg/day is permitted, Significant bleeding risk or coagulation disorders, at screening, Have received any live or live-attenuated vaccines (including but not limited to varicella-zoster virus or measles, oral polio, nasal influenza) within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study treatment, History of clinically significant Central Nervous System (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at screening, Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML prior to randomization, Score yes” on item 4 or item 5 of the suicidal ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past 6 months, or yes” on any item of the suicidal behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years, prior to randomization, Participants who have had a splenectomy, Active clinically significant systemic bacterial, viral, parasitic or fungal infections in the judgement of the investigator prior to randomization (e.g. infections requiring hospitalization or i.v. antibiotics), Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder, Participants with a known immunodeficiency syndrome (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, drug induced immune deficiency), or tested positive for Human immunodeficiency virus (HIV) antibody, at screening, Resting QT interval corrected by Fridericia’s formula (QTcF) =450 msec (male) or =460 msec (female) at pretreatment (prior to randomization)
研究者
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