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STUDY DESIGN

The ASCLEPIOS Trial 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, double-blind, active comparator-controlled, parallel-group, multicenter, Phase 3 studies in patients with relapsing MS, approximately 40% of whom were DMT treatment naïve. Patients were randomized to double-dummy subcutaneous KESIMPTA (20 mg every 4 weeks) or oral Aubagio® (teriflunomide) (14 mg daily) for up to 30 months. Primary end point was ARR. Key MRI end points were number of Gd+ T1 lesions and annualized rate of new or enlarging T2 lesions. A key clinical end point was 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

ARR, annualized relapse rate; CDP, confirmed disability progression; DMT, disease-modifying therapy; Gd+, gadolinium-enhancing; MOA, mechanism of action; MRI, magnetic resonance imaging; MS, multiple sclerosis.

IMPORTANT SAFETY INFORMATION

Contraindications: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema.

Warnings and Precautions

Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies....

INDICATION

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults...

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Reference: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp.