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

STATUS

Recruiting
End date

May 6, 2027
participants needed

1400
sponsor

Sanofi

Updated on 24 February 2025

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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 of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
The study intervention duration will vary ranging from approximately 12 to 40 months.
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.

Details

Condition	Multiple Sclerosis
Age	18years - 55years
Clinical Study Identifier	NCT06141473
Sponsor	Sanofi
Last Modified on	24 February 2025

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
	The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
	The participant must have at least 1 of the following prior to screening
	≥1 documented relapse within the previous year OR
	≥2 documented relapses within the previous 2 years, OR
	≥1 documented Gd enhancing lesion on an MRI scan within the previous year
	Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion Criteria
	The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
	The participant has a history of infection or may be at risk for infection
	The presence of psychiatric disturbance or substance abuse
	History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment
	History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN)
	A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis
	The participant has had a relapse in the 30 days prior to randomization
	The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans
	The above information is not intended to contain all considerations relevant
	to a participant's potential participation in a clinical trial

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

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

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Study Definition

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