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

Conditions

• Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Frexalimab — DRUG
  SAR441344 Solution for IV infusion
• Teriflunomide — DRUG
  Aubagio oral tablet
• Placebo infusion — DRUG
  Solution for IV infusion
• Placebo tablet — DRUG
  Oral tablet
• MRI contrast-enhancing agents — DRUG
  IV, as per respective label
• Cholestyramine — DRUG
  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.
• Activated charcoal — DRUG
  oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Study Details

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.

Key Dates

Start date

Dec 13, 2023

Status verified

May 2026

Primary completion

May 6, 2027

Completion

May 6, 2027

Study Design

Enrollment

1,655 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Frexalimab
  Participants will receive Frexalimab infusion and placebo tablet.
• Active Comparator: Teriflunomide
  Participants will receive teriflunomide tablet and placebo infusion.

Primary Outcome Measure

Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses [ Time Frame: Until Week 156 ]

Locations (99)

Find similar trials in Birmingham, AL

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