EUCTR2020-000647-30-FI进行中（未招募）1 期
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 18 to 60 years of age inclusive
- •- Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
- •- Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
- •- The participant must have documented evidence of disability progression observed during the 12 months before screening
- •- Absence of clinical relapses for at least 24 months
- •- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •- Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •- Is not a woman of child bearing potential (WOCBP)
- •- Is a WOCBP and agrees to use an acceptable contraceptive method
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1700
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- The participant has conditions that would adversely affect study participation such as short life expectancy.
- •- History of organ transplant.
- •- Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections that would adversely affect study participation.
- •- Persistent chronic or active or recurring system infection, that may adversely affect participation or IMP administration in this study, as judged by the Investigator.
- •- History of malignancy within 5 years prior to screening.
- •- History of alchohol or drug abuse within 1 year prior to screening.
- •- Hospitalized for psychiatric disease within 2 years prior to screening.
- •- Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
- •- A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
- •- A platelet count <150 000/µL at the screening visit.
- •-A history of significant bleeding event within 6 months prior to screening, according to the Investigator’s judgment such as, but not limited to cerebral or gastrointestinal bleeding.
- •- Lymphocyte count below the lower limit of normal at screening.
- •- Recent live (attenuated) vaccine within 2 months before the first treatment visit.
- •- Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
- •- The participant has received medications/treatments for MS within a specified time frame.
- •- Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes
- •- Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
- •- Contraindications to magnetic resonance imaging (MRI).
- •NOTE: Other Inclusion/Exclusion criteria may apply.
研究者
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