EUCTR2020-004785-19-DE进行中（未招募）1 期
A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, 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
- 160
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
- •I 01. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- •I 02. The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
- •I 03. The participant must have at least 1 documented relapse within the previous year, or =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.
- •I 04. Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
- •I 05. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •I 06. Capable of giving signed informed consent.
- •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
- •E 01. The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
- •E 02. The participant has conditions or situations that would adversely affect participation in this study.
- •E 03. The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
- •E 04. History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
- •E 05. Allergies to humanized monoclonal antibodies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
- •E 06. The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
- •E 07. The participant has taken other investigational drug within 3 months or 5-halflive, whichever is longer, before the screening visit.
- •E 08. The participant has an EDSS score >5.5 at the first screening visit.
- •E 09. The participant has had a relapse in the 30 days prior to randomization.
- •E 10. Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
- •E 11. Abnormal laboratory test(s) at Screening.
- •E 12. Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (antiHBc Ab) at screening or within 3 months prior to first dose of study intervention.
- •E 13. Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
研究者
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