FREVIVA
Research type
Research Study
Full title
A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis
IRAS ID
1008950
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-504359-29
Clinicaltrials.gov Identifier
Research summary
Multiple sclerosis a chronic autoimmune disease where the immune system attacks the central nervous system. Therapies halting the disability progression in people with MS are needed. This study evaluates the experimental medicine frexalimab for adults with secondary progressive MS with no acute exacerbation of symptoms. Main objective: Evaluate the effect of frexalimab in delaying disability progression, measured by changes in disability status, walking impairment, or manual dexterity over 6-month intervals. EFC17504 is a randomized, double-blind study designed to evaluate how effective and safe frexalimab is compared to placebo in slowing disability progression. Participants will have different study durations due to when they are 1st assigned to frexalimab or placebo (Longest being 51 months and shortest 27). The study will end when the number of events, prespecified in the study protocol, is reached. “Double blinded” means that neither the participants nor the study doctors know who is given study medicine or placebo, making sure that the study results are not influenced. The study will consist of the following study periods: Screening; randomization/start of treatment Participants have 2 in 3 chances to receive frexalimab or 1 in 3 to receive placebo; treatment period); safety follow-up and end of study. The treatment is randomly chosen for each participant, by chance using a computer program. Participants would intravenously receive frexalimab or placebo. Placebo looks like the medicine being tested, but it doesn’t have any active ingredient. The MRI scan- will require contrast-enhancing agents. People aged 18 to 60 years, diagnosed with secondary progressive MS with no relapses, who have documented evidence of disability progression in the past year and within a score parameter evaluating the progression of MS (3.0 – 6.0) can participate in the study. Medical history of patients will be analaysed. If any of exclusion criteria are met, they cannot participate.
REC name
Wales REC 1
REC reference
24/WA/0005
Date of REC Opinion
18 Mar 2024
REC opinion
Further Information Favourable Opinion