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Study type
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About
Primary 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
Full description
Approximately 62 months including the 8 weeks post-treatment visit
Enrollment
Sex
Ages
Volunteers
Inclusion 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 treatment 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.
The participant is receiving anticoagulant/antiplatelet therapies, including:
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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
125 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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