Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Summary

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Multiple Sclerosis

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 60 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Sanofi

Last updated on ClinicalTrials.gov

October 13, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites