EUCTR2018-003927-12-ES进行中（未招募）1 期
A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •- Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- •- Participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
- •- Participant must have at least 1 documented relapse within the previous year, =2 documented relapses within the previous 2 years, or =1 active Gadolinium (Gd)-enhancing brain lesion on an magnetic resonance imaging (MRI) scan in the past 6 months and prior to screening.
- •- A female participant must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
- •- Male participants, whose partners are of childbearing potential (including breastfeeding women), must accept to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
- •- Male participants whose partners are pregnant must use, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
- •- Male participants must have agreed not to donate sperm from the inclusion up to 3 months after the last dose.
- •- Participant must have given written informed consent prior to undertaking any study-related procedure.
- •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 160
- •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 been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis (SPMS).
- •- Requirement for concomitant treatment that could bias the primary evaluation.
- •- Contraindication for MRI.
- •- Contraindications to use MRI Gd contrast-enhancing preparations.
- •- History of infection with the human immunodeficiency virus (HIV).
- •- History of active or latent tuberculosis.
- •- Any other active infections that would adversely affect participation or investigational medicinal product (IMP) administration in this study, as judged by the Investigator.
- •- Presence of any screening laboratory or ECG values outside normal limits that are considered in the Investigator’s judgment to be clinically significant.
- •- Presence of liver injury.
- •- At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody.
- •- Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
- •- Participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
- •- Participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
- •- Participant is receiving anticoagulant/antiplatelet therapies.
- •- Participant has taken other investigational drugs within 3 months or 5 half lives, whichever is longer, before screening visit.
- •- Participant has an Expanded Disability Status Scale (EDSS) score >5.5 at screening visit.
- •- Participant has had a relapse in the 30 days prior to randomization.
- •- Participant is pregnant or a breastfeeding woman.
- •- History or presence of significant other concomitant illness.
- •- The participant has received medications/treatments for MS within a specified time frame.
研究者
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