demyelinating disease Multiple sclerosis
Conditions
Interventions
Bruton's tyrosine kinase inhibitor. In phase A of the study the patient
receives a maximum of four tablets per day to achieve a daily dose of 5, 15, 30
or 60 mg, depending on the arm to which the pa
Sponsors
Sanofi B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Participants must have completed treatment in the DRI15928 study - Female participants must continue to use an acceptable effective contraception method of birth control from inclusion and until the last study dose, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
Exclusion criteria
Exclusion criteria: -The participant has a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment. -The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study. -The participant has received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing trreatment with SAR442168. Washout periods after treatment with non-study DMTs should be respected except for interferons or glatiramer acetate treatment. -The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes. Note: Such drugs need to be stopped at least 5 half-lives before study drug administration. The participant is receiving anticoagulant/antiplatelet therapies, including: • Acetylsalicylic acid (aspirin) • Antiplatelet drugs (eg, clopidogrel) • Warfarin (vitamin K antagonist) • Heparin, including low molecular weight heparin (antithrombin agents) • Dabigatran (direct thrombin inhibitor) • Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors) Note: All above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand. -Prior/concurrent clinical study experience -The participant is taking part in another interventional clinical trial of another drug substance. -Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), serious adverse events (SAEs), safety findings on magnetic resonance imaging (MRI), potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG), or vital signs during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of new gadolinium (Gd)-enhancing T1-hyperintense lesions by brain MRI - Number of new or enlarging T2 lesions - Total number of Gd-enhancing T1-hyperintense lesions - Number of relapses (annualized relapse rate [ARR]) during the study period - Change in Expanded Disability Status Scale (EDSS) score from baseline over time | — |
Countries
Netherlands
Outcome results
None listed