Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: SAR442168; Placebo; Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Intervention description: Pharmaceutical form: Film coated tablet; Route of administration: Oral; Pharmaceutical form: Film coated tablet; Route of administration: Oral; Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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.
    

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.