A Phase 3 randomized, double-blind, efficacy and safety study comparing frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis (FREVIVA)

Research summary

This is a parallel, Phase 3 study with 2-arms for treatment that are blinded/masked for participants, the Investigator, any Investigator site staff, and the Sponsor. The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy in delaying the disability progression and the safety of up to 48 months administration of frexalimab intravenous (IV) every 4 weeks (q4w) 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 inclusion and no exclusion criteria. Study details include: • This event-driven study will have variable duration ranging from approximately 24 to 48 months (see Section 4.4 of the protocol). • The treatment duration will vary ranging from approximately 24 to 48 months. • The follow up duration after the end of treatment will be 6 months. • 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.

Principal Investigator

Dr Silvia Messina

Contact us

Email: ana.cavey@ouh.nhs.uk

IRAS number

1008950