NL-OMON48153已完成2 期
A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis - DRI15928
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
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 99（—）
入选标准
- •- The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed
- •- The participant must have been diagnosed with RMS according to the 2017 revision of the
- •McDonald diagnostic criteria.
- •- The participant must have at least 1 documented relapse within the previous year, *2 documented relapses within the previous 2 years, or *1 active Gd-enhancing brain lesion on an 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. Menopause is defined as being amenorrheic for *2 years with serum
- •follicle-stimulating hormone (FSH) level >30 UI/L.
- •- 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.
排除标准
- •- The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
- •- The participant has conditions or situations that would adversely affect participation in this study, including but not limited to: A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist; Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator; A requirement for concomitant treatment that could bias the primary evaluation; Contraindication for MRI, ie, presence of pacemaker, metallic implants in high-risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material
- •(eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol-scheduled MRI; Contraindications to use MRI Gd contrast-enhancing preparations.
- •- The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study, including but not limited to: A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation and/or antirejection therapy; A history of diagnosis of progressive multifocal leukoencephalopathy (PML) or evidence of findings suggestive of PML on the baseline MRI; A history of infection with the human immunodeficiency virus; A history of active or latent tuberculosis; Any other active infections that would adversely affect participation or IMP administration in this study, as judged by the Investigator; A history of malignancy within 10 years prior to the first screening visit, except effectively treated carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell carcinoma of the skin; A history of alcohol or drug abuse within 1 year prior to the first screening visit; A history of any psychiatric disease, behavioral condition, or depression requiring hospitalization within 2 years prior to the first screening visit; 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 defined as underlying hepatobiliary disease or screening alanine aminotransferase (ALT) >3 x upper limit of normal (ULN).
- •- 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.
- •- The participant has any of the following: A bleeding disorder or known platelet dysfunction at any time prior to the first screening visit; A platelet count <150 000/*L at the screening visit.
- •- The participant has a lymphocyte count less than the lower limit of normal (LLN) at the screening visit.
- •- The participant has received any live (attenuated) vaccine within 2 months before the first treatment visit.
- •- The participant has received any of the following medications/treatments within the specified time frame before any baseline assessment (no wash-out is required forinterferons beta or glatiramer acetate treatments):
- •-Systemic corticosteroids, adrenocorticotropic hormone 1 month prior to screening MRI scan
- •-Dimethyl fumarate 1 month prior to randomization
- •-Intravenous (IV) immun
研究者
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