Phase 2 Study of Subcutaneous Ublituximab Injection at Different Sites and Using Prefilled Pen Versus Syringe in Adults with Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)