Phase 3 Study Comparing Subcutaneous and Intravenous Frexalimab in Adults With Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the differences between subcutaneous SC and intravenous IV administration of frexalimab in adults aged 18 to 60 years with relapsing multiple sclerosis RMS and non-relapsing secondary progressive multiple sclerosis nrSPMS. This Phase 3, randomized, open-label study aims to compare the pharmacokinetics, safety, and efficacy of these two methods of delivering frexalimab over a one-year period. Participants include males and females diagnosed with MS who meet specific clinical criteria related to their disease type and progression. Participants will be randomly assigned to receive frexalimab either as an SC injection every 4 weeks using a home self-administration on-body delivery system after training and agreement starting from Part B or as an IV infusion every 4 weeks. The treatment duration covers 48 weeks for the first two parts of the study, with an optional third part continuing until the start of a long-term safety study. Regular visits occur monthly between weeks 4 and 24, then less frequently up to the end of the study, with follow-up visits for those who discontinue treatment early. During the study, participants will attend up to 17 scheduled visits and undergo assessments including MRI scans with contrast, blood tests to measure drug levels and immune responses, and evaluations of disability progression. Researchers will monitor adverse events, the presence of antibodies to the drug, and participant preferences for SC versus IV administration. Follow-up continues for six months after treatment ends to assess long-term safety and outcomes. The study collects data on pharmacokinetics and clinical effects at multiple timepoints up to week 96 and beyond for some participants.

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