FREXALT
Research type
Research Study
Full title
Master protocol of two independent, randomized, double-blind, Phase 3 studies comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis
IRAS ID
1008892
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-504358-36
Clinicaltrials.gov Identifier
Research summary
Multiple sclerosis (MS) is a chronic autoimmune disease where the immune system attacks the central nervous system causing weakness, incoordination, numbness, and impairment in speech and vision.
Therapies halting the brain damage and the disability worsening in people with multiple sclerosis are needed. This EFC17919 study evaluates the experimental medicine frexalimab for the treatment of adults with relapsing forms of multiple sclerosis.
The primary goal of the study is to evaluate the effect of frexalimab on relapses by looking at the number of relapses per year during the study.
Frexalimab is compared to the standard of care in relapsing multiple sclerosis, teriflunomide, in reducing the frequency of relapses and slowing disability worsening, and in assessing its safety and tolerability. EFC17919 comprises of two (EFC17919A and EFC17919B), independent, identical, randomized, double-blind studies. Participants will have different study durations depending on when the participants are assigned to frexalimab or teriflunomide (approximately 40 months for the first participant assigned to treatment and approximately 20 months for the last). Studies will end when the number of events, pre-specified in the study protocol, is reached. “Double-blinded” means that neither the people participating, nor the study doctors know who is given the study medicine or the comparator. This is done to make sure that the study results are not influenced in any way.
Evidence from a Phase 2 study of frexalimab demonstrated that it is well tolerated and effective in reducing the number of new active brain lesions in people with relapsing multiple sclerosis after 12 weeks of treatment. This study wants to test whether this benefit is maintained for up to 40 months and whether frexalimab can delay disability worsening.REC name
Wales REC 1
REC reference
24/WA/0004
Date of REC Opinion
19 Mar 2024
REC opinion
Further Information Favourable Opinion