EUCTR2020-000644-55-GR进行中（未招募）1 期
A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •- 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 criter
- •- 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:
- •-- =1 documented relapse within the previous year OR
- •-- =2 documented relapses within the previous 2 years, OR
- •-- =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
- •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 ptential (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
- •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 1200
- •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 multiplesclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiplesclerosis (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
- •- - The participant has been diagnosed with primary progressive
- •multiplesclerosis (PPMS) according to the 2017 revision of the McDonald
- •diagnostic criteria or with nonrelapsing secondary progressive
- •multiplesclerosis (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
- •- Confirmed screening ALT >2 × ULN
- •- 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
- •- 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/µL 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
- •- 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
研究者
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