NCT06141473

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Frexalimab	SAR441344 Solution for IV infusion
DRUG	Teriflunomide	Aubagio oral tablet
DRUG	Placebo infusion	Solution for IV infusion
DRUG	Placebo tablet	Oral tablet
DRUG	MRI contrast-enhancing agents	IV, as per respective label
DRUG	Cholestyramine	oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.
DRUG	Activated charcoal	oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Timeline

• Start date: 2023-12-13
• Primary completion: 2027-05-06
• Completion: 2027-05-06
• First posted: 2023-11-21
• Last updated: 2026-04-13

Locations

384 sites across 41 countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study