demyelinating disease Multiple sclerosis
Conditions
Interventions
Enrolled participants will be randomly assigned in a 2: 1 ratio to 60 mg oral
SAR442168 (obtained from dose determination study
DRI15928) or placebo corresponding daily.
Randomisation will be stratif
Sponsors
Sanofi B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * 18 to 55 year old male or female with PPMS * EDSS score at screening from 2.0 to 6.5 points, inclusive * Positive cerebrospinal fluid (oligoclonal bands/elevated IgG index) at screening or prior history * If female of childbearing potential: - not pregnant or breastfeeding, and agrees to use acceptable contraceptive method during the intervention period (at a minimum until after the last IMP dose)
Exclusion criteria
Exclusion criteria: -History of infection or at risk for infection -Presence of psychiatric disturbance or substance abuse -Confirmed laboratory or ECG abnormalities, during the screening visit, deemed by the investigator to be clinically significant. -Conditions that may predispose the participant to excessive bleeding -Conditions that would adversely affect participation in study or make primary efficacy endpoint non-evaluable -A requirement for concomitant treatment that could bias the primary evaluation, such as any of the medications/treatments - stated in the protocol - within the specified time frame before any baseline assessment -Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes -Receiving anticoagulant/antiplatelet therapies -Sensitivity to study interventions, or drug or other allergy that, per Investigator, contraindicates participation in the study. -Previously exposed to any BTK inhibitor, including SAR442168. -Taken other investigational drugs within 3 months or 5 half-lives, whichever is longer, before SCR. -Contraindication for MRI (People with contraindication to gadolinium (Gd) can be enrolled but cannot receive Gd during MRI scan.) -Institutionalized because of regulatory or legal order; prisoners or participants who are legally institutionalized. -Any country-related regulation that would prevent entering the study, if applicable. -Not suitable for participation, whatever the reason, as judged by Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures or not able to follow protocol assessments -Dependent on Sponsor or Investigator -Employees of study site or directly involved in conduct of study, or immediate family members of such individuals. -Any other situation during study course that may raise ethics considerations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the time to onset of CDP (confirmed for at least 3 months) assessed by the EDSS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints from time to event will be analyzed in a similar manner to the primary efficacy endpoint. • Time to start of composite CDP • Time to start of 3 months CDP • Time to CDI • Total number of new and / or growing hyperintense T2 lesions using MRI • Percentage change in brain volume loss using MRI • Change in cognitive function using the SDMT • Change in the score on the "quality of life" questionnaire • Adverse reactions (AEs), serious adverse events (SAEs), safety results on MRI, and possible clinically significant abnormalities in laboratory results, on electrocardiogram (ECG) or in vital signs during the study period. | — |
Countries
Netherlands
Outcome results
None listed