jRCT2021200035已完成不适用
A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio) in participants with relapsing forms of multiple sclerosis (GEMINI 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi K.K.
- 入组人数
- 900
- 主要终点
- Annualized Adjudicated Relapse Rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 55age old under（—）
- 性别
- All
入选标准
- •The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
- •The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
- •The participant has an expanded disability status scale (EDSS) score <=5.5 at the first Screening Visit
- •The participant must have at least 1 of the following prior to screening:
- •a) >=1 documented relapse within the previous year OR
- •b) >=2 documented relapses within the previous 2 years, OR
- •c) >=1 documented Gd enhancing lesion on an MRI scan within the previous year
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:
- •Refrain from donating sperm
- •Plus either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- •Must agree to use contraception/barrier as detailed below
- •- Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply:
- •- Is not a Woman of child-bearing potential (WOCBP)
- •- Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded
- •A WOCBP must have a negative highly sensitive pregnancy test at screening and within 24 hours before the first dose of study intervention.
- •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (SPMS)
- •The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection
- •Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
- •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
- •The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
- •The participant has any of the following:
- •- A bleeding disorder or known platelet dysfunction at any time prior to the screening visit
- •- A platelet count <150 000/microL at the screening visit
- •The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit
- •The presence of psychiatric disturbance or substance abuse
- •Prior/concomitant therapy
- •The participant is receiving potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
- •The participant is receiving anticoagulant/antiplatelet therapies
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Annualized Adjudicated Relapse Rate
时间窗: Up to approximately 36 months
Number of confirmed adjudicated protocol defined relapses
次要结局
- Time to onset of confirmed disability worsening confirmed over at least 6 months(Up to approximately 36 months)
- Change in cognitive function(From Baseline up to approximately 36 months)
- Time to confirmed disability improvement(From Baseline up to approximately 36 months)
- Percent Change in Brain volume loss (BVL)(From 6 months up to approximately 36 months)
- Change in Multiple Sclerosis Quality of Life(From Baseline up to approximately 36 months)
- Population Pharmacokinetics - Concentration SAR442168 and relevant metabolites at 6 months(6 Months)
- Population Pharmacokinetics - Concentration of SAR442168 and relevant metabolites at 12 Months(12 Months)
- Change in CHI3L1 levels(From Baseline until end of study approximately 36 months)
- Population Pharmacokinetics Concentration of SAR442168 and relevant metabolites at 9 Months(9 Months)
- Change in plasma NfL(From Baseline until end of study approximately 36 months)
- Change in lymphocyte Phenotype(From Baseline until end of study approximately 36 months)
- Changes in serum Immunoglobulin levels(From Baseline until end of study (up to 36 months))
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