Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

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.