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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events (AEs), serious adverse events (SAEs), safety findings on<br /><br>magnetic resonance imaging (MRI), potentially clinically significant<br /><br>abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG), or vital<br /><br>signs during the study period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Number of new gadolinium (Gd)-enhancing T1-hyperintense lesions by brain MRI<br /><br>- Number of new or enlarging T2 lesions<br /><br>- Total number of Gd-enhancing T1-hyperintense lesions<br /><br>- Number of relapses (annualized relapse rate [ARR]) during the study period<br /><br>- Change in Expanded Disability Status Scale (EDSS) score from baseline over<br /><br>time</p><br>