2024-514495-41-00招募中3 期
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 487
- 试验地点
- 106
- 主要终点
- 6-month composite Confirmed Disability Progression (cCDP)
研究概览
简要总结
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in Primary Progressive Multiple Sclerosis (PPMS)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 55 years of age inclusive
- •Diagnosis of PPMS according to the 2017 McDonald criteria
- •Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
- •Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
- •Contraceptive use consistent with local regulations for individuals 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 childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method - the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication). - the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy
排除标准
- •Participant has conditions that would adversely affect study participation such as short life expectancy.
- •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
- •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).
- •Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection 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 alcohol 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.
结局指标
主要结局
6-month composite Confirmed Disability Progression (cCDP)
6-month composite Confirmed Disability Progression (cCDP)
次要结局
- 6-month Confirmed Disability Progression (CDP)
- 3-month composite Confirmed Disability Progression (cCDP)
- Change in T2 hyperintense lesions by MRI
- Time to onset of confirmed disability improvement (CDI)
- Percent change in Brain volume (BV)
- Change in cognitive function as assessed by SDMT
- Change in cognitive function as assessed by CVLT-II
- Change in Multiple Sclerosis Quality of Life
- Safety and Tolerability
- Population pharmacokinetics
- Change in plasma neurofilament light chain (NfL)
- Change in lymphocyte phenotype subsets
- Changes in serum Immunoglobulin level
- Change in serum chitinase-3 like protein 1 (Chi3L1)
研究者
Clinical Sciences and Operations
Scientific
Genzyme Corp.
研究点 (106)
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