(COMB157G2301) A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

The PI of this project was:

This project was funded by: Novartis

The term of this project was: March 2017 to November 2020

The number of subjects scanned during this project was: 5

The study is designed in conjunction with a second study of identical design, conducted in
parallel, to provide efficacy, safety, and tolerability data for ofatumumab subcutaneous (sc) compared to oral (po) teriflunomide (Aubagio®) in patients with relapsing Multiple Sclerosis (MS). The data will support regulatory approval to make ofatumumab sc available for clinical use worldwide as a treatment for this
patient population. The primary objective is to demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.

The key secondary objectives are to evaluate if ofatumumab 20 mg sc q4 weeks is superior to
teriflunomide 14 mg po once daily on the following efficacy measures: (a) time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on The Expanded Disability Status Scale (EDSS), (b) time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on
EDSS, (c) time to disability improvement as measured by 6-month confirmed improvement (6mCDI)
on EDSS, (d) number of T1 Gd-enhancing lesions per MRI scan, (e) number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate), (f) rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline.