Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Phase 2 Active not recruiting 129 enrolled Sanofi

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To evaluate pharmacokinetics of SAR441344

Timeline

Start: 2021-06-07
Primary completion: 2022-09-21
Completion: 2027-08-23

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SC SAR441344 300 mg; Rate ratio 0.21 (95% CI 0.08 to 0.56) NCT04879628 ↗

registry analysis (superiority test); Placebo vs IV SAR441344 1200 mg; Rate ratio 0.11 (95% CI 0.03 to 0.38) NCT04879628 ↗

release “Frexalimab met primary endpoint with 89% reduction in new gadolinium-enhancing T1 brain lesions achieved at Week 12 in the higher-dose treatment arm, compared with placebo” sanofi.com ↗

Publications

Vermersch P, Granziera C, Mao-Draayer Y, Cutter G, Kalbus O, Staikov I, Dufek M, Saubadu S, Bejuit R, Truffinet P, Djukic B, Wallstroem E, Giovannoni G; Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15;390(7):589-600. doi: 10.1056/NEJMoa2309439.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Frexalimab	Monoclonal antibody	300 mg	Intravenous
Subject	Frexalimab	Monoclonal antibody	1200 mg	Intravenous