The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.
Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company C (52/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.