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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

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 Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Recruiting

Open to: ALL

Age: 18.0 - 60.0

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 this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue 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 Dec 2026

INTERVENTIONAL

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

Intervention Arm Group : Frexalimab;

Intervention Type : DRUG
Intervention Description : Solution for IV infusion

Intervention Arm Group : Placebo;

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

Intervention Arm Group : Frexalimab;Placebo;



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.

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: NCT06141486
Last updated 20 February 2026

This page is to help you find out about a research study and if you may be able to take part

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