Primary progressive multiple sclerosis (PPMS) study of BTK inhibitor SAR442168 (PERSEUS)

INTERVENTION: Intervention1: Arm name: SAR442168 Intervention name: SAR442168 60 mg or Placebo matched to SAR442168 : Dose formulation Tablet Unit dose strength(s) 60 mg Dosage level(s) Once daily Route of administration Oral Control Intervention1: Arm name: Placebo: Unit dose strength(s) 0 mg Dose formulation Tablet Dosage level(s) Once daily Route of administration Oral CONDITION: Health Condition 1: G35‐ Multiple sclerosis PRIMARY OUTCOME: Time to onset of 6‐month confirmed disability Progression (CDP) defined as follows: ; ‐ Increase of â?¥1.0 point from the baseline EDSS score when the baseline score is â?¤5.0, OR ; ‐ Increase of â?¥0.5 point when the baseline EDSS score is 5.5 ; Timepoint: 24 weeks SECONDARY OUTCOME: Time to onset of 3‐month CDP as assessed by the EDSS score ; Time to onset of sustained 20% increase in the 9‐HPT confirmed over at least 3 months ; Time to onset of sustained 20% increase in the T25‐FW test confirmed over at least 3 months ; Total number of new and/or enlarging T2‐hyperintense lesions as detected by MRI, ; defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit ; Timepoint: 24 weeks INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the following criteria apply: Age: I 01. The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent Type of participant and disease characteristics: I 02. The participant must have been diagnosed with PPMS in according with the 2017 revision of the McDonald diagnostic criteria I 03. The participant must have an EDSS score at screening from 2.0 to 6.5 points, inclusive. I 04. The participant must have, at screening, disease duration from the onset of MS symptoms of: ‐ <15 years in participants with EDSS scores at screening >5.0, OR ‐ <10 years in participants with EDSS scores at screening â?¤5.0 I 05. The participant must have positive CSF (isoelectric focusing evidence of oligoclonal bands and/or elevated IgG index) either during screening or previous his