dose-finding study for sar442168 in relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: primary objective: to determine the dose-response relationship for sar442168 to reduce the number of new active brain lesions. secondary objectives: * to evaluate efficacy of sar442168 on disease activity as assessed by imaging measures. * to evaluate the safety and tolerability of sar442168.

the total study duration was 24 weeks which included a screening period of 4 weeks, a treatment period of 16 weeks, and a follow-up period of up to 4 weeks. participants who completed the week 16 visit were proposed to be enrolled in a long-term extension safety and efficacy study to assess safety, tolerability and efficacy of sar442168.

Eligibility criteria:
inclusion criteria: * participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. * participant was diagnosed with relapsing multiple sclerosis (rms) according to the 2017 revision of the mcdonald diagnostic criteria. * participant must had at least 1 documented relapse within the previous year, or greater than or equal to (\>=) 2 documented relapses within the previous 2 years, or \>=1 active gadolinium (gd) enhancing brain lesion on an mri scan in the past 6 months and prior to screening. * a female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. menopause was defined as being amenorrheic for \>=12 months with serum follicle-stimulating hormone (fsh) level greater than (\>) 30 international units per liters. * male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted 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 were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose. * male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose. * participant had given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * the participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the mcdonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis. * requirement for concomitant treatment that could bias the primary evaluation. * contraindication for mri. * contraindications to use mri gd contrast-enhancing preparations. * history of infection with the human immunodeficiency virus (hiv). * history of active or latent tuberculosis. * any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the investigator. * presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the investigator's judgment to be clinically significant. * presence of liver injury. * at screening, the participant was positive for hepatitis b surface antigen and/or hepatitis b core antibody and/or was positive for hepatitis c antibody. * bleeding disorder or known platelet dysfunction at any time prior to screening visit. * participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit. * participant was receiving strong inducers or inhibitors of cytochrome p450 3a (cyp3a) or cyp2c8 hepatic enzymes. * participant was receiving anticoagulant/antiplatelet therapies. * participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit. * participant had an expanded disability status scale score \>5.5 at first screening visit. * participant had a relapse in the 30 days prior to randomization. * participant was pregnant or a breastfeeding woman. * history or presence of significant other concomitant illness. * the participant had received medications/treatments for multiple sclerosis within a specified time frame. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.