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Contact Information:

Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610
contact-us@sanofi.com


Study Location:

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Be Part of Research - Trial Details - Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

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

Recruiting

Open to: ALL

Age: 18.0 - 55.0

Medical Conditions

Multiple Sclerosis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 May 2027

Publications

"Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available."; "39899371"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : SAR441344 Solution for IV infusion

Intervention Arm Group : Frexalimab;

Intervention Type : DRUG
Intervention Description : Aubagio oral tablet

Intervention Arm Group : Teriflunomide;

Intervention Type : DRUG
Intervention Description : Solution for IV infusion

Intervention Arm Group : Teriflunomide;

Intervention Type : DRUG
Intervention Description : Oral tablet

Intervention Arm Group : Frexalimab;

Intervention Type : DRUG
Intervention Description : IV, as per respective label

Intervention Arm Group : Frexalimab;Teriflunomide;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Frexalimab;Teriflunomide;

Intervention Type : DRUG
Intervention Description : oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Intervention Arm Group : Frexalimab;Teriflunomide;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8261003
    Canterbury
    Kent
    CT1 3NG
  • Investigational Site Number : 8260013
    London
    London, City of
    E11 1NR
  • Investigational Site Number : 8260001
    Exeter
    Devon
    EX2 5DW
  • Investigational Site Number : 8261008
    Salford
    M6 8HD
  • Investigational Site Number : 8260010
    Inverness
    IV2 3UJ

Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610
contact-us@sanofi.com



The study is sponsored by Sanofi





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Read full details for Trial ID: NCT06141473
Last updated 26 January 2026

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