Clinical Trials List
Protocol NumberEFC16033
NCT Number(ClinicalTrials.gov Identfier)NCT04410978
Completed
2020-10-01 - 2024-12-31
Phase III
Recruiting6
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
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Trial Applicant
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Sponsor
Sanofi
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- YA-FANG CHEN Division of Radiology
- HSUEH-WEN HSUEH Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李英玄醫師 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蔡宛蓁 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Relapsing Multiple Sclerosis
Objectives
Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
Test Drug
SAR442168 60mg or Teriflunomide 14mg or placebo
Active Ingredient
SAR442168
Dosage Form
tablet
Dosage
60mg
Endpoints
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses [ Time Frame: Up to approximately 36 months ]
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses
Inclution Criteria
Inclusion criteria :
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:
≥1 documented relapse within the previous year OR
≥2 documented relapses within the previous 2 years, OR
≥1 documented Gd enhancing brain 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 WOCBP OR
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) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time.
A WOCBP must have a negative highly sensitive pregnancy test urine or serum, as required by local regulations) within the screening period 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
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:
≥1 documented relapse within the previous year OR
≥2 documented relapses within the previous 2 years, OR
≥1 documented Gd enhancing brain 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 WOCBP OR
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) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time.
A WOCBP must have a negative highly sensitive pregnancy test urine or serum, as required by local regulations) within the screening period 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
Exclusion Criteria
Exclusion criteria:
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
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
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 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 strong inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2C8 hepatic enzymes as listed in Appendix 8A (Section 10.8).
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.
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
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
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 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 strong inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2C8 hepatic enzymes as listed in Appendix 8A (Section 10.8).
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.
The Estimated Number of Participants
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Taiwan
13 participants
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Global
900 participants
