Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Status:
Recruiting
Trial end date:
2027-05-06
Target enrollment:
Participant gender:
Summary
The purpose of each study is to independently measure the annualized relapse rate (ARR) with
administration of frexalimab compared to a daily oral dose of teriflunomide in male and
female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the
time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible
for enrollment as long as they meet all the inclusion criteria and none of the exclusion
criteria.
Study details include:
- This event-driven study will have variable duration of approximately 40 months for the
first participant being randomized and approximately 20 months for the last participant
randomized.
- The study intervention duration will vary ranging from approximately 20 to 40 months.
- The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3
follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and
then every 3 months.