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

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

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.

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-13

Primary Completion

2027-05-06

Completion

2027-05-06

FDA Drug

Yes

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

Study Locations