Ask to take part

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
Multiple Sclerosis, Chronic Progressive
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.

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.

  • Investigational Site Number : 8260013
    London
    London, City Of
    E11 1NR
  • Investigational Site Number : 8260001
    Exeter
    Devon
    EX2 5DW
  • Investigational Site Number : 8260007
    Cardiff
    Vale Of Glamorgan, The
    CF14 4XW
  • Investigational Site Number : 8260009
    Fazakerley
    Liverpool
    L9 7LJ
  • Investigational Site Number : 8260004
    Oxford
    Oxfordshire
    OX3 9DU
  • Investigational Site Number : 8260003
    Canterbury
    Kent
    CT1 3NG
  • Investigational Site Number : 8260005
    Swansea
    Neath Port Talbot
    SA6 6SG
  • Investigational Site Number : 8260011
    Gwent
    NP20 2UB
  • Investigational Site Number : 8260006
    Newcastle Upon Tyne
    NE2 4HH
  • Investigational Site Number : 8260008
    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: NCT06141486
Last updated 10 March 2025

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