TG Therapeutics says enrollment commenced for Phase 3 trial of BRIUMVI

TG Therapeutics (TGTX) announced that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI, the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis. BRIUMVI is currently approved in the United States, as well as several ex-US territories, as a one-hour intravenous infusion administered twice a year, following the starting dose, in adults with RMS. This is a Phase 3, non-inferiority, randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous BRIUMVI compared to IV BRIUMVI in adult participants with RMS. Participants will be randomized into one of three arms: an every 8 week regimen of subcutaneous BRIUMVI, an every 12 week regimen of subcutaneous BRIUMVI or the currently approved IV BRIUMVI dosing schedule. The primary endpoint of the trial is non inferior exposure of subcutaneous BRIUMVI compared to IV BRIUMVI with respect to area under the curve at week 24.