The ASCLEPIOS Trials Video
Watch a brief overview of the KESIMPTA® (ofatumumab) pivotal trial results, hosted by a lead investigator.
ASCLEPIOS I & II Study Design
ASCLEPIOS I and II were 2 identical, randomized, active-controlled, double-blind Phase 3 studies in patients with relapsing MS, approximately 40% of whom were DMT treatment naïve. Patients were randomized to double-dummy SC KESIMPTA (20 mg every 4 weeks) or oral Aubagio® (teriflunomide) (14 mg daily) for up to 30 months. Primary end point was ARR. Key secondary end points were number of Gd+ T1 lesions and annualized rate of NE T2 lesions, and reduction in risk of 3-month CDP. Treatment duration was variable based on end-of-study criteria. Maximum duration: 120 weeks; median duration: 85 weeks.1
40% of patients in the pivotal trials were treatment naïve2
ARR, annualized relapse rate; CDP, confirmed disability progression; DMT, disease-modifying therapy; Gd+, gadolinium-enhancing; MS, multiple sclerosis; NE, new or enlarging; SC, subcutaneous.