Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis

INTERVENTION: Product Code: SAR442168 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Not available CAS Number: 1971920‐73‐6 Current Sponsor code: SAR442168 Other descriptive name: PRN2246 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Product Code: SAR442168 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Not available CAS Number: 1971920‐73‐6 Current Sponsor code: SAR442168 Other descriptive name: PRN2246 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ CONDITION: Relapsing multiple sclerosis ; MedDRA version: 21.1 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: ; Primary end point(s): 1 ‐ Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) : Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); 2 ‐ Number of Participants with Potentially Clinically Significant Abnormalities : Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs during the study period.; Main Objective: To determine the long‐term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods Timepoint(s) of evaluation of this end point: 1, 2 : Baseline to final follow‐up visit ( Month 60 plus 8 weeks) SECONDARY OUTCOME: ; Secondary end point(s): 1 ‐ Number of new gadolinium (Gd)‐enhancing T1 hyperintense lesions : New gadolinium (Gd)‐enhancing T1 hyperintense lesions determined by brain Magnetic Resonance Imaging (MRI) ; 2 ‐ Number of new or enlarging T2 lesions : T2 lesions, a marker of inflammatory activity and brain tissue destruction in RMS will be evaluated by MRI ; 3 ‐ Total number of Gd‐enhancing T1‐hyperintense lesions : Total number of Gd‐enhancing T1‐hyperintense lesions ; 4 ‐ Number of participants wih relapse (Annualized Relapse rate) : Annualized Relapse rate is defined as the number of participants with relapse during the study period. ; 5 ‐ Change in Expanded Disability Status Scale (EDSS) from baseline over time : Standard EDSS assessments of neurological symptoms in each of 7 functional domains (visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral and bowel/bladder) will be performed. Ambulation will also be scored as part of the evaluation.; ; Timepoint(s) of evaluation of this end point: 1, 2, 3, 5 : Baseline to final follow‐up visit ( Month 60 plus 8 weeks) ; 4 : Baseline to Month 60; INCLUSION CRITERIA: ‐ Participants must have completed treatment in the DRI15928 study ‐ Male participants whose partners are pregnant must use, during sexual intercourse, a condom from inclusion u ‐ Female participants must continue to use 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 has undergone sterilization at least 3 months earlier or is postmenopausal. Menopause is defined as being amenorrheic for =12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L. ‐ Male participants whose partners are of childbearing potential (including breastfeeding women), must accept 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.